Trial Outcomes & Findings for A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (NCT NCT01065454)

Last Updated: 2026-08-20

Results Overview

Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

202 participants

Primary outcome timeframe

Baseline and visit 6 (16 weeks)

Results posted on

2026-08-20

Participant Flow

Only subjects with symptomatic pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study. Subjects must have been pre-treated with optimized CHF therapy.

301 subjects were screened in 84 study centers in 18 countries worldwide. 99 of the 301 screened subjects were not randomized (adverse event \[1\], protocol violation \[1\], screen failure \[87\], withdrawal by subject \[10\]). Of the 202 subjects randomized, one subject did not receive any study medication.

Participant milestones

Participant milestones
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg Participants received riociguat 0.5 mg tid (fixed dose).	Placebo Participants received placebo tid.
Treatment STARTED	67	33	32	69
Treatment COMPLETED	54	28	23	57
Treatment NOT COMPLETED	13	5	9	12
Long-term extension (LTE) STARTED	49	27	23	51
Long-term extension (LTE) Treated during long-term extension phase	49	26	23	44
Long-term extension (LTE) COMPLETED	0	0	0	0
Long-term extension (LTE) NOT COMPLETED	49	27	23	51

Reasons for withdrawal

Reasons for withdrawal
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg Participants received riociguat 0.5 mg tid (fixed dose).	Placebo Participants received placebo tid.
Treatment Adverse Event	7	4	3	6
Treatment Death	1	0	0	0
Treatment Non-compliance	1	0	0	1
Treatment Protocol Decision	0	0	3	2
Treatment Protocol Violation	1	0	1	0
Treatment Withdrawal by Subject	3	1	2	3
Long-term extension (LTE) Adverse Event	26	12	9	16
Long-term extension (LTE) Death	6	3	4	8
Long-term extension (LTE) Lack of Efficacy	1	0	1	1
Long-term extension (LTE) Non-compliance	1	0	0	3
Long-term extension (LTE) Physician Decision	4	0	1	5
Long-term extension (LTE) Protocol deviation	2	3	1	2
Long-term extension (LTE) Protocol Violation	1	0	0	1
Long-term extension (LTE) Lost to Follow-up	0	1	0	1
Long-term extension (LTE) Withdrawal by Subject	7	6	2	5
Long-term extension (LTE) Site terminated by the sponsor	0	0	1	0
Long-term extension (LTE) Study terminated by the sponsor	0	1	3	2
Long-term extension (LTE) Not treated	0	1	0	7
Long-term extension (LTE) Receiving Adempas outside the study	1	0	1	0

Baseline Characteristics

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=67 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=33 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=32 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=69 Participants Participants received placebo tid.	Total n=201 Participants Total of all reporting groups
Age, Continuous	59.3 Years STANDARD_DEVIATION 10.8 • n=5 Participants	55.1 Years STANDARD_DEVIATION 13.2 • n=109 Participants	57.2 Years STANDARD_DEVIATION 9.9 • n=133 Participants	58.9 Years STANDARD_DEVIATION 11.2 • n=86 Participants	58.1 Years STANDARD_DEVIATION 11.2 • n=1912 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	3 Participants n=109 Participants	6 Participants n=133 Participants	8 Participants n=86 Participants	29 Participants n=1912 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	30 Participants n=109 Participants	26 Participants n=133 Participants	61 Participants n=86 Participants	172 Participants n=1912 Participants
Body mass index	28.87 kg/m^2 STANDARD_DEVIATION 5.27 • n=5 Participants	28.16 kg/m^2 STANDARD_DEVIATION 4.72 • n=109 Participants	29.20 kg/m^2 STANDARD_DEVIATION 5.64 • n=133 Participants	28.65 kg/m^2 STANDARD_DEVIATION 5.89 • n=86 Participants	28.73 kg/m^2 STANDARD_DEVIATION 5.44 • n=1912 Participants
6-minute walking distance	380.9 Meters STANDARD_DEVIATION 125.80 • n=5 Participants	401.9 Meters STANDARD_DEVIATION 101.75 • n=109 Participants	416.6 Meters STANDARD_DEVIATION 95.77 • n=133 Participants	382.1 Meters STANDARD_DEVIATION 123.51 • n=86 Participants	390.5 Meters STANDARD_DEVIATION 116.94 • n=1912 Participants
Left ventricular ejection fraction (LVEF)	28.4 Percentage STANDARD_DEVIATION 5.72 • n=5 Participants	28.8 Percentage STANDARD_DEVIATION 4.54 • n=109 Participants	27.0 Percentage STANDARD_DEVIATION 5.21 • n=133 Participants	27.1 Percentage STANDARD_DEVIATION 5.02 • n=86 Participants	27.8 Percentage STANDARD_DEVIATION 5.24 • n=1912 Participants
Etiology Ischemic cardiomyopathy	30 Participants n=5 Participants	12 Participants n=109 Participants	14 Participants n=133 Participants	34 Participants n=86 Participants	90 Participants n=1912 Participants
Etiology Non-ischemic cardiomyopathy	37 Participants n=5 Participants	20 Participants n=109 Participants	17 Participants n=133 Participants	34 Participants n=86 Participants	108 Participants n=1912 Participants
Etiology Data missing	0 Participants n=5 Participants	1 Participants n=109 Participants	1 Participants n=133 Participants	1 Participants n=86 Participants	3 Participants n=1912 Participants
WHO (World Health Organization) functional class II	35 Participants n=5 Participants	20 Participants n=109 Participants	23 Participants n=133 Participants	42 Participants n=86 Participants	120 Participants n=1912 Participants
WHO (World Health Organization) functional class III	31 Participants n=5 Participants	13 Participants n=109 Participants	9 Participants n=133 Participants	23 Participants n=86 Participants	76 Participants n=1912 Participants
WHO (World Health Organization) functional class IV	1 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants	4 Participants n=86 Participants	5 Participants n=1912 Participants
Number of participants with diabetes mellitus (including subtypes)	30 Participants n=5 Participants	10 Participants n=109 Participants	13 Participants n=133 Participants	34 Participants n=86 Participants	87 Participants n=1912 Participants
Glomerular filtration rate (GFR)	65.1 mL/min/1.73m^2 STANDARD_DEVIATION 19.10 • n=5 Participants	72.6 mL/min/1.73m^2 STANDARD_DEVIATION 22.70 • n=109 Participants	72.0 mL/min/1.73m^2 STANDARD_DEVIATION 17.90 • n=133 Participants	68.7 mL/min/1.73m^2 STANDARD_DEVIATION 19.90 • n=86 Participants	68.7 mL/min/1.73m^2 STANDARD_DEVIATION 19.91 • n=1912 Participants
Number of participants with atrial fibrillation	9 Participants n=5 Participants	3 Participants n=109 Participants	3 Participants n=133 Participants	9 Participants n=86 Participants	24 Participants n=1912 Participants
Number of participants with atrial flutter	0 Participants n=5 Participants	0 Participants n=109 Participants	1 Participants n=133 Participants	1 Participants n=86 Participants	2 Participants n=1912 Participants
Number of participants with pacemaker rhythm	17 Participants n=5 Participants	9 Participants n=109 Participants	7 Participants n=133 Participants	17 Participants n=86 Participants	50 Participants n=1912 Participants
Baseline drug and device therapy Cardiac devices	38 Participants n=5 Participants	17 Participants n=109 Participants	21 Participants n=133 Participants	44 Participants n=86 Participants	120 Participants n=1912 Participants
Baseline drug and device therapy Angiotensin-converting enzyme inhibitors	50 Participants n=5 Participants	25 Participants n=109 Participants	21 Participants n=133 Participants	46 Participants n=86 Participants	142 Participants n=1912 Participants
Baseline drug and device therapy Angiotensin II receptor blockers	20 Participants n=5 Participants	8 Participants n=109 Participants	10 Participants n=133 Participants	19 Participants n=86 Participants	57 Participants n=1912 Participants
Baseline drug and device therapy Aldosterone antagonists	51 Participants n=5 Participants	26 Participants n=109 Participants	23 Participants n=133 Participants	53 Participants n=86 Participants	153 Participants n=1912 Participants
Baseline drug and device therapy Beta-blockers	31 Participants n=5 Participants	16 Participants n=109 Participants	21 Participants n=133 Participants	32 Participants n=86 Participants	100 Participants n=1912 Participants
Baseline drug and device therapy Beta-blockers with alpha-blocking activity	30 Participants n=5 Participants	15 Participants n=109 Participants	11 Participants n=133 Participants	30 Participants n=86 Participants	86 Participants n=1912 Participants
Baseline drug and device therapy Loop diuretics	62 Participants n=5 Participants	31 Participants n=109 Participants	29 Participants n=133 Participants	68 Participants n=86 Participants	190 Participants n=1912 Participants
Baseline drug and device therapy Thiazide diuretics	12 Participants n=5 Participants	3 Participants n=109 Participants	7 Participants n=133 Participants	10 Participants n=86 Participants	32 Participants n=1912 Participants
Baseline drug and device therapy Cardiac glycosides	28 Participants n=5 Participants	12 Participants n=109 Participants	6 Participants n=133 Participants	28 Participants n=86 Participants	74 Participants n=1912 Participants
Baseline drug and device therapy Oral anticoagulants	38 Participants n=5 Participants	16 Participants n=109 Participants	15 Participants n=133 Participants	33 Participants n=86 Participants	102 Participants n=1912 Participants
Baseline drug and device therapy Amiodarone	9 Participants n=5 Participants	3 Participants n=109 Participants	4 Participants n=133 Participants	8 Participants n=86 Participants	24 Participants n=1912 Participants

PRIMARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Population: Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF \[safety analysis set\]/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.

Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16	-6.1 mmHg Standard Deviation 9.68	-0.8 mmHg Standard Deviation 8.41	-4.5 mmHg Standard Deviation 7.35	-4.0 mmHg Standard Deviation 9.00

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Population: Per-protocol set (PPS) - A subject was included in the PPS if he/she was valid for SAF/ITT and showed no major protocol deviations affecting efficacy. Only participants with a baseline and at least one post-baseline measurement were included in this analysis.

The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=45 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=23 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=19 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=48 Participants Participants received placebo tid.
Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16	1.98 Percentage Standard Deviation 7.084	0.46 Percentage Standard Deviation 7.866	-0.21 Percentage Standard Deviation 5.969	1.28 Percentage Standard Deviation 9.259

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\*(PAPmean - PCWP)/CO

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16	-78.15 dynscm^-5 Standard Deviation 125.261	-33.05 dynscm^-5 Standard Deviation 99.322	-51.44 dynscm^-5 Standard Deviation 124.107	-36.97 dynscm^-5 Standard Deviation 157.523

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80\*(PAPmean - PCWP)\*BSA/CO

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16	-152.60 dynscm^-5*m^2 Standard Deviation 250.366	-61.763 dynscm^-5*m^2 Standard Deviation 202.138	-91.65 dynscm^-5*m^2 Standard Deviation 237.256	-76.47 dynscm^-5*m^2 Standard Deviation 311.693

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80\*(SAPmean - RAPmean)/CO

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16	-340.44 dynscm^-5 Standard Deviation 394.87	-118.72 dynscm^-5 Standard Deviation 369.865	-67.46 dynscm^-5 Standard Deviation 315.097	-94.37 dynscm^-5 Standard Deviation 431.049

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80\*(SAPmean - RAPmean)\*BSA/CO

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16	-651.98 dynscm^-5*m^2 Standard Deviation 757.617	-217.14 dynscm^-5*m^2 Standard Deviation 742.465	-100.31 dynscm^-5*m^2 Standard Deviation 612.460	-195.11 dynscm^-5*m^2 Standard Deviation 853.927

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16	-2.16 mmHg Standard Deviation 4.795	-1.01 mmHg Standard Deviation 5.224	-1.65 mmHg Standard Deviation 4.652	-1.37 mmHg Standard Deviation 7.001

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=53 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16	-3.93 mmHg Standard Deviation 9.381	0.25 mmHg Standard Deviation 9.001	-2.818 mmHg Standard Deviation 7.842	-2.68 mmHg Standard Deviation 7.791

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=45 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=23 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=21 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16	0.584 mm Standard Deviation 2.344	1.140 mm Standard Deviation 2.986	0.304 mm Standard Deviation 2.109	0.393 mm Standard Deviation 1.586

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=55 Participants Participants received placebo tid.
Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16	-7.69 mmHg Standard Deviation 14.251	-2.89 mmHg Standard Deviation 12.333	-5.86 mmHg Standard Deviation 11.589	-4.49 mmHg Standard Deviation 13.717

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100\*(LVEDV - LVESV)/LVEDV

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=52 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16	6.599 Percentage Standard Deviation 43.187	12.659 Percentage Standard Deviation 41.769	5.529 Percentage Standard Deviation 48.322	11.121 Percentage Standard Deviation 42.989

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=52 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16	1.805 mL Standard Deviation 31.735	6.415 mL Standard Deviation 28.832	1.507 mL Standard Deviation 34.033	7.295 mL Standard Deviation 32.311

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=52 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16	6.599 mL Standard Deviation 43.187	12.659 mL Standard Deviation 41.769	5.529 mL Standard Deviation 48.322	11.121 mL Standard Deviation 42.989

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=49 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=22 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=21 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=53 Participants Participants received placebo tid.
E-wave Deceleration Time - Change From Baseline to Week 16	2.857 msec Standard Deviation 31.470	-0.636 msec Standard Deviation 38.138	8.000 msec Standard Deviation 39.542	-1.208 msec Standard Deviation 43.937

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=44 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=20 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=20 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=48 Participants Participants received placebo tid.
Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16	-0.247 E/A ratio Standard Deviation 0.957	0.141 E/A ratio Standard Deviation 1.261	-0.063 E/A ratio Standard Deviation 0.884	-0.175 E/A ratio Standard Deviation 1.079

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=55 Participants Participants received placebo tid.
6-minute Walking Distance (6MWD) - Change From Baseline to Week 16	31.425 m Standard Deviation 83.386	25.379 m Standard Deviation 84.244	-2.784 m Standard Deviation 90.324	17.857 m Standard Deviation 80.851

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
WHO (World Health Organization) Functional Class - Change From Baseline to Week 16 -1	20.4 Percentage of participants	21.4 Percentage of participants	22.7 Percentage of participants	19.6 Percentage of participants
WHO (World Health Organization) Functional Class - Change From Baseline to Week 16 0	74.1 Percentage of participants	75 Percentage of participants	68.2 Percentage of participants	71.4 Percentage of participants
WHO (World Health Organization) Functional Class - Change From Baseline to Week 16 1	5.6 Percentage of participants	3.6 Percentage of participants	9.1 Percentage of participants	8.9 Percentage of participants

SECONDARY outcome

Timeframe: At visit 6 (16 weeks)

Population: Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis.

The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=67 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=33 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=32 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=69 Participants Participants received placebo tid.
Percentage of Participants With Clinical Worsening	23.9 Percentage of participants	15.1 Percentage of participants	15.6 Percentage of participants	21.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=55 Participants Participants received placebo tid.
Borg CR 10 Scale - Change From Baseline to Week 16	0.269 Scores on a scale Standard Deviation 1.900	-0.804 Scores on a scale Standard Deviation 2.319	-0.682 Scores on a scale Standard Deviation 1.516	0.187 Scores on a scale Standard Deviation 2.640

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=56 Participants Participants received placebo tid.
EQ-5D Utility Score - Change From Baseline to Week 16	0.073 Scores on a scale Standard Deviation 0.211	0.016 Scores on a scale Standard Deviation 0.242	0.004 Scores on a scale Standard Deviation 0.166	0.018 Scores on a scale Standard Deviation 0.201

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The MLHF total score can range from 0 (best) to 105 (worst).

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=54 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=22 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=55 Participants Participants received placebo tid.
Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16	-10.789 Scores on a scale Standard Deviation 22.232	-5.132 Scores on a scale Standard Deviation 14.111	-7.595 Scores on a scale Standard Deviation 18.651	0.211 Scores on a scale Standard Deviation 15.964

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=45 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=26 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=17 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=44 Participants Participants received placebo tid.
Cystatin C - Change From Baseline to Week 16	39.3 ng/mL Standard Deviation 232.7	11.2 ng/mL Standard Deviation 218.5	71.2 ng/mL Standard Deviation 140.8	58.6 ng/mL Standard Deviation 242.9

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=50 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=28 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=21 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=54 Participants Participants received placebo tid.
N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16	-168.42 pg/mL Standard Deviation 1585.28	-213.48 pg/mL Standard Deviation 1204.24	-215.71 pg/mL Standard Deviation 769.16	171.51 pg/mL Standard Deviation 2123.55

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=34 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=24 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=15 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=44 Participants Participants received placebo tid.
Troponin T - Change From Baseline to Week 16	0.005 µg/L Standard Deviation 0.027	-0.008 µg/L Standard Deviation 0.042	-0.001 µg/L Standard Deviation 0.006	0.003 µg/L Standard Deviation 0.015

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=49 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=25 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=19 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16	0.020 µmol/L Standard Deviation 0.115	0.026 µmol/L Standard Deviation 0.118	0.006 µmol/L Standard Deviation 0.098	0.020 µmol/L Standard Deviation 0.090

SECONDARY outcome

Timeframe: Baseline and visit 6 (16 weeks)

Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.

Outcome measures

Outcome measures
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg n=50 Participants Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).	Riociguat (Adempas, BAY63-2521) up to 1 mg n=27 Participants Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).	Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg n=18 Participants Participants received riociguat 0.5 mg tid (fixed dose).	Placebo n=51 Participants Participants received placebo tid.
Osteopontin - Change From Baseline to Week 16	-13.400 µg/mL Standard Deviation 44.931	-0.852 µg/mL Standard Deviation 22.396	-2.722 µg/mL Standard Deviation 29.379	-4.588 µg/mL Standard Deviation 77.576

Adverse Events

Riociguat (Adempas, BAY63-2521) up to 2 mg - Main Study Phase

Serious events: 23 serious events

Other events: 61 other events

Deaths: 1 deaths

Riociguat (Adempas, BAY63-2521) up to 1 mg - Main Study Phase

Serious events: 7 serious events

Other events: 29 other events

Deaths: 1 deaths

Riociguat (Adempas, BAY63-2521)Fixed 0.5 mg - Main Study Phase

Serious events: 7 serious events

Other events: 24 other events

Deaths: 1 deaths

Placebo - Main Study Phase

Serious events: 18 serious events

Other events: 52 other events

Deaths: 0 deaths

Riociguat (Adempas, BAY63-2521) - LTE Phase

Serious events: 116 serious events

Other events: 136 other events

Deaths: 29 deaths

Serious adverse events

Serious adverse events
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg - Main Study Phase n=67 participants at risk Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg) in the main phase.	Riociguat (Adempas, BAY63-2521) up to 1 mg - Main Study Phase n=33 participants at risk Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg) in the main phase.	Riociguat (Adempas, BAY63-2521)Fixed 0.5 mg - Main Study Phase n=32 participants at risk Participants received riociguat 0.5 mg tid (fixed dose) in the main phase.	Placebo - Main Study Phase n=69 participants at risk Participants received placebo tid in the main phase.	Riociguat (Adempas, BAY63-2521) - LTE Phase n=142 participants at risk Participants received riociguat in doses of 0.5 mg, 1 mg, and 2 mg tid in the LTE phase.
Endocrine disorders Goitre	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Glaucoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Acute left ventricular failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Acute myocardial infarction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Angina pectoris	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Arrhythmic storm	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial fibrillation	4.5% 3/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.7% 11/142 • Number of events 15 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial flutter	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial tachycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Bradycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac arrest	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure	10.4% 7/67 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.1% 3/33 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	31.7% 45/142 • Number of events 81 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure acute	3.0% 2/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.7% 11/142 • Number of events 20 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure chronic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac tamponade	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiomyopathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiorenal syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Coronary artery disease	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Left ventricular failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Low cardiac output syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Mitral valve incompetence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Palpitations	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Right ventricular failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Sinus node dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Sinus tachycardia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Tachycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular arrhythmia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular fibrillation	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular tachycardia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.0% 10/142 • Number of events 13 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Ear and labyrinth disorders Meniere's disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Retinal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Rhegmatogenous retinal detachment	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Constipation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Faecaloma	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastritis erosive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Incarcerated inguinal hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Subileus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Vomiting	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Asthenia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Chest pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Death	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Discomfort	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions General physical health deterioration	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Hernia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Hypothermia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Medical device site discharge	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Multiple organ dysfunction syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Non-cardiac chest pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Pyrexia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Sudden cardiac death	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Sudden death	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Bile duct stone	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cardiac cirrhosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cholangitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Appendicitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bacteraemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bronchitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations COVID-19	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Cellulitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Enterobacter bacteraemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Epididymitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Erysipelas	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastroenteritis	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastroenteritis clostridial	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Haemophilus infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Infected skin ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Influenza	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Localised infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Medical device site infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Orchitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Osteomyelitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Peritonitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pneumonia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.7% 18/142 • Number of events 19 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pneumonia staphylococcal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Postoperative wound infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Respiratory tract infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Sepsis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Septic shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tooth abscess	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Urinary tract infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Wound infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Concussion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Internal injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Ligament rupture	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Scar	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Seroma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Underdose	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Atrial pressure increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood glucose increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood magnesium decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Colonoscopy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Culture positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Ejection fraction decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations International normalised ratio decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations International normalised ratio increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Mean arterial pressure increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Respiratory syncytial virus test positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Transplant evaluation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperphagia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Cerebral infarction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Cerebrovascular accident	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Coma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dizziness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dizziness postural	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Embolic stroke	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Ischaemic stroke	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Presyncope	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Seizure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Syncope	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.9% 14/142 • Number of events 16 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Toxic encephalopathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device dislocation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device extrusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device inappropriate shock delivery	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device ineffective	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device lead damage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device malfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Depression	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Panic attack	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Acute kidney injury	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.0% 10/142 • Number of events 10 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Chronic kidney disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders End stage renal disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal impairment	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urinary retention	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Pelvic cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 12 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Abdominal adhesiolysis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Bladder polypectomy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cardiac device reprogramming	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cardiac pacemaker replacement	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cardiac resynchronisation therapy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Carpal tunnel decompression	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cataract operation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Gastric bypass	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Heart transplant	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Hernia repair	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Intervertebral disc operation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Knee arthroplasty	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Thyroidectomy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Transurethral bladder resection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Umbilical hernia repair	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Uterine dilation and curettage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Ventricular assist device insertion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Aortic stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Circulatory collapse	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Haemodynamic instability	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hypotension	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hypovolaemic shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Shock haemorrhagic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.

Other adverse events

Other adverse events
Measure	Riociguat (Adempas, BAY63-2521) up to 2 mg - Main Study Phase n=67 participants at risk Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg) in the main phase.	Riociguat (Adempas, BAY63-2521) up to 1 mg - Main Study Phase n=33 participants at risk Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg) in the main phase.	Riociguat (Adempas, BAY63-2521)Fixed 0.5 mg - Main Study Phase n=32 participants at risk Participants received riociguat 0.5 mg tid (fixed dose) in the main phase.	Placebo - Main Study Phase n=69 participants at risk Participants received placebo tid in the main phase.	Riociguat (Adempas, BAY63-2521) - LTE Phase n=142 participants at risk Participants received riociguat in doses of 0.5 mg, 1 mg, and 2 mg tid in the LTE phase.
Cardiac disorders Ventricular tachycardia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.9% 14/142 • Number of events 18 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Congenital, familial and genetic disorders Type V hyperlipidaemia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Eye haematoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Ear and labyrinth disorders Auditory disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Goitre	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Anaemia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.1% 4/33 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	14.8% 21/142 • Number of events 23 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Angina pectoris	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Aortic valve incompetence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Arrhythmia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial fibrillation	9.0% 6/67 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	16.2% 23/142 • Number of events 38 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial flutter	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrial tachycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrioventricular block complete	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Atrioventricular block first degree	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Bradycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Bundle branch block right	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure	6.0% 4/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	14.8% 21/142 • Number of events 35 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure acute	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure chronic	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac perforation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiogenic shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Cardiovascular disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Left ventricular dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Left ventricular failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Low cardiac output syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Myocardial ischaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Palpitations	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 10 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Pericardial effusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Pulmonary valve incompetence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Right ventricular failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Sinus arrhythmia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Sinus node dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular arrhythmia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular extrasystoles	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Cardiac disorders Ventricular fibrillation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Ear and labyrinth disorders Vertigo	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Adrenal mass	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Hyperparathyroidism	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Hyperthyroidism	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Hypothyroidism	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Pituitary-dependent Cushing's syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Pseudo Cushing's syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Thyroid cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Endocrine disorders Thyroid mass	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Cataract	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Conjunctival haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Conjunctival hyperaemia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Cornea verticillata	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Diabetic retinopathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Diplopia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Dry eye	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Eye movement disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Eye swelling	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Eyelid bleeding	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Eyelid oedema	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Glaucoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Lacrimation disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Ocular discomfort	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Ocular hyperaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Periorbital eczema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Periorbital oedema	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Retinal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Retinal ischaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Swelling of eyelid	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Vision blurred	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Visual field defect	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Visual impairment	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Eye disorders Vitreous haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal discomfort	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal distension	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal pain	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Abdominal pain upper	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 10 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Anal fissure	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Anorectal polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Ascites	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Barrett's oesophagus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Colitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Constipation	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.5% 4/32 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	11.3% 16/142 • Number of events 21 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Dental caries	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Diarrhoea	17.9% 12/67 • Number of events 14 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	15.2% 5/33 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.2% 5/69 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	19.7% 28/142 • Number of events 48 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Duodenitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Dyspepsia	9.0% 6/67 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	18.2% 6/33 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.9% 14/142 • Number of events 15 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Eructation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Faeces discoloured	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Flatulence	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastric mucosal hypertrophy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastric polyps	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastritis erosive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastrointestinal pain	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.0% 10/142 • Number of events 13 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Gingival pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Haematemesis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Hiatus hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Infrequent bowel movements	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Intestinal congestion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Intestinal polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Nausea	16.4% 11/67 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.2% 5/69 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.0% 17/142 • Number of events 25 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oesophageal pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oesophagitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oral blood blister	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Oral pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Precancerous lesion of digestive tract	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Rectal spasm	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Retching	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Sicca syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Umbilical hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Gastrointestinal disorders Vomiting	7.5% 5/67 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 25 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Asthenia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 12 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Chest discomfort	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Chest pain	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.0% 17/142 • Number of events 24 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Chills	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Exercise tolerance decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Face oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Fatigue	6.0% 4/67 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.4% 3/32 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.7% 18/142 • Number of events 23 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Feeling abnormal	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Feeling hot	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Hypothermia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Implant site pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Influenza like illness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Infusion site oedema	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Localised oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Medical device site swelling	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Non-cardiac chest pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Oedema	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Oedema peripheral	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.5% 4/32 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	15.5% 22/142 • Number of events 35 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Peripheral swelling	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Physical deconditioning	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Puncture site haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Pyrexia	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Temperature intolerance	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
General disorders and administration site conditions Treatment noncompliance	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Biliary colic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cholecystitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Cholelithiasis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatic pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hepatomegaly	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Immune system disorders Drug hypersensitivity	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Immune system disorders Hypersensitivity	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Immune system disorders Rubber sensitivity	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Immune system disorders Seasonal allergy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Abscess limb	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Acute sinusitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Appendicitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bacterial infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bed bug infestation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Breast abscess	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bronchitis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	13.4% 19/142 • Number of events 27 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Bronchitis moraxella	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations COVID-19	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Candida infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Catheter site infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Cellulitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Conjunctivitis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Conjunctivitis bacterial	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Cystitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Diverticulitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Ear infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Eye infection bacterial	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Eyelid folliculitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Folliculitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Fungal skin infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Furuncle	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastroenteritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.4% 3/32 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastroenteritis viral	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Gastrointestinal infection	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Genital infection fungal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Groin infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Herpangina	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Herpes simplex	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Herpes zoster	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Hordeolum	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Implant site infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Infected bite	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Infected skin ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Influenza	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.2% 13/142 • Number of events 18 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Laryngitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Laryngitis viral	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Localised infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Lower respiratory tract infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Medical device site infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Nasopharyngitis	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.1% 3/33 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	19.0% 27/142 • Number of events 61 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Onychomycosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Oral fungal infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Oral infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Osteomyelitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Otitis externa	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Otitis media	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Otitis media acute	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pharyngitis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pneumonia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.0% 10/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pneumonia aspiration	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Postoperative wound infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pyelonephritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Pyelonephritis chronic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Rectal abscess	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Respiratory tract infection	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Respiratory tract infection viral	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Rhinitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Sepsis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Sinusitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Skin bacterial infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tinea infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tinea pedis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tonsillitis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tonsillitis bacterial	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tooth abscess	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Tooth infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Trichophytosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Upper respiratory tract infection	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	10.1% 7/69 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.0% 17/142 • Number of events 32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Urethritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Urinary tract infection	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Varicella zoster virus infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Viral infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Viral upper respiratory tract infection	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Infections and infestations Wound infection	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Accident	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Animal bite	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Arteriovenous fistula site haematoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Joint injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Limb injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Lip injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Post procedural fever	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Post procedural inflammation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Post-traumatic neck syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Traumatic pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Underdose	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Unintentional medical device removal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Alanine aminotransferase increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Biopsy breast	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Biopsy thyroid gland	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood cholesterol increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood creatine phosphokinase increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood creatinine increased	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	10.1% 7/69 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.0% 10/142 • Number of events 14 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood glucose fluctuation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood glucose increased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood iron decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood lactic acid increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood magnesium decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood potassium decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood potassium increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood pressure decreased	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood pressure orthostatic increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood pressure systolic decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood sodium decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood testosterone decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood urea increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Blood uric acid increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations C-reactive protein abnormal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Carbohydrate deficient transferrin increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Cardioactive drug level increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Culture positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Cystatin C increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Faecal occult blood positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Gamma-glutamyltransferase increased	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Glomerular filtration rate decreased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Glutamate dehydrogenase increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Haemoglobin decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Heart rate decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Heart rate increased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Heart sounds abnormal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Inflammatory marker test	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Influenza A virus test positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations International normalised ratio decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations International normalised ratio increased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.1% 4/33 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations KL-6 increased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Lipase increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Liver function test increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations N-terminal prohormone brain natriuretic peptide increased	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Platelet count decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Prohormone brain natriuretic peptide increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Pulmonary arterial pressure increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Pulmonary arterial wedge pressure increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Respiratory syncytial virus test positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Transaminases increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Transferrin saturation decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Transplant evaluation	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Troponin I increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Urine output decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Walking distance test abnormal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Weight decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations Weight increased	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Investigations White blood cell count decreased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Decreased appetite	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Dehydration	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Fluid retention	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Gout	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.7% 18/142 • Number of events 33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyperuricaemia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypervolaemia	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 10 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypokalaemia	6.0% 4/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.2% 13/142 • Number of events 25 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Increased appetite	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Iron deficiency	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Lactose intolerance	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Arthralgia	6.0% 4/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.0% 17/142 • Number of events 27 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Arthritis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Arthrofibrosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Back pain	6.0% 4/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	14.1% 20/142 • Number of events 24 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Bone pain	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Bursitis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Carpal collapse	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Chest wall haematoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Jaw cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Joint deposit	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Muscle contracture	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.1% 2/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.9% 14/142 • Number of events 22 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Musculoskeletal and connective tissue disorders Vertebral osteophyte	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma recurrent	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic naevus	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile wart	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Amnesia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Aphasia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Ataxia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Balance disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Bell's palsy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Burning sensation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Cerebral infarction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dementia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Diabetic neuropathy	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dizziness	16.4% 11/67 • Number of events 13 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.1% 4/33 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	15.6% 5/32 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	10.1% 7/69 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	20.4% 29/142 • Number of events 47 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dizziness exertional	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dizziness postural	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Dysgeusia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Head discomfort	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Headache	14.9% 10/67 • Number of events 10 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.1% 4/33 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	10.1% 7/69 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.7% 18/142 • Number of events 21 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Hemianaesthesia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Hemiparaesthesia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Hypersomnia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Hypoaesthesia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.2% 6/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Intracranial calcification	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Lacunar infarction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Lethargy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Memory impairment	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Mental impairment	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Metabolic encephalopathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Migraine	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Muscle contractions involuntary	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Neuralgia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Orthostatic intolerance	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Paraesthesia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Presyncope	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Sciatica	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Sensory disturbance	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Somnolence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.8% 4/69 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Syncope	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Taste disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Nervous system disorders Tremor	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device extrusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device lead issue	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Product issues Device power source issue	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Agitation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Anxiety	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Anxiety disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Delirium	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Depressed mood	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Depression	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.3% 9/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Dysphemia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Dysphoria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Insomnia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Mental status changes	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Mood altered	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Nervousness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Panic attack	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Post-traumatic stress disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Psychiatric disorders Sleep disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Chronic kidney disease	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Dysuria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders End stage renal disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Haematuria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Incontinence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Nephropathy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Nocturia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Prerenal failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Proteinuria	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal atrophy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal failure	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 9 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Renal impairment	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.2% 13/142 • Number of events 17 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urge incontinence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urinary retention	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Renal and urinary disorders Urine odour abnormal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Breast cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Breast discharge	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Breast pain	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Breast swelling	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Erection increased	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Gynaecomastia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Haematospermia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Menopausal disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Prostatitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Uterine polyp	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 5/67 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.1% 3/33 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	12.5% 4/32 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	7.7% 11/142 • Number of events 14 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 3/67 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.1% 3/33 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.4% 3/32 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	14.5% 10/69 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	23.9% 34/142 • Number of events 43 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea paroxysmal nocturnal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.5% 3/67 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	5.6% 8/142 • Number of events 11 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Nocturnal dyspnoea	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Obstructive sleep apnoea syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Sinus congestion	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord inflammation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Vocal cord leukoplakia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Alopecia	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 6 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Onychalgia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Photodermatosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Pruritus	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.9% 2/69 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.9% 7/142 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Rash	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Skin disorder	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Solar lentigo	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Skin and subcutaneous tissue disorders Xanthelasma	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Social circumstances Menopause	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cardiac resynchronisation therapy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.8% 4/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cataract operation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Cyst removal	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Hernia hiatus repair	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Implantable defibrillator replacement	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Large intestinal polypectomy	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Retinal operation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Swan ganz catheter placement	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Tooth extraction	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Varicose vein operation	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Surgical and medical procedures Wound drainage	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Angiodysplasia	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Aortic arteriosclerosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Aortic stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Arteriosclerosis Moenckeberg-type	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Cyanosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Distributive shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Flushing	3.0% 2/67 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	6.2% 2/32 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Haematoma	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 1/69 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hot flush	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hypertension	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hypotension	11.9% 8/67 • Number of events 8 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	15.2% 5/33 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	9.4% 3/32 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	4.3% 3/69 • Number of events 5 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	20.4% 29/142 • Number of events 36 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Hypovolaemic shock	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Intermittent claudication	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	2.1% 3/142 • Number of events 4 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Jugular vein occlusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Orthostatic hypotension	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.5% 5/142 • Number of events 7 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral arterial occlusive disease	1.5% 1/67 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.0% 1/33 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 3 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral artery occlusion	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral vascular disorder	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral vein stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Peripheral venous disease	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/142 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Phlebitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	1.4% 2/142 • Number of events 2 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Raynaud's phenomenon	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Shock haemorrhagic	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Steal syndrome	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Subclavian vein stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Superficial vein thrombosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Thrombophlebitis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	3.1% 1/32 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.
Vascular disorders Venous stenosis	0.00% 0/67 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/33 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/32 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.00% 0/69 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.	0.70% 1/142 • Number of events 1 • From first study intervention through 30 days ± 3 days after end of study intervention, including the main study and Long-Term Extension (LTE) phase. This included approximately 112 days (maximum) following the main study intervention and 1046 days (median) during the LTE phase. All-cause mortality considers all deaths occurring at any time during the study up to last contact were included, including deaths reported up to 83 days after treatment.

Additional Information

Therapeutic Area Head

Bayer

Email: [email protected]

Results disclosure agreements

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