Trial Outcomes & Findings for Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery (NCT NCT02152761)

Last Updated: 2020-08-19

Results Overview

Mixed Model for Repeated Measures (MMRM) of change from baseline in total LBM (kg) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least three doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg has been added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

251 participants

Primary outcome timeframe

baseline, weeks 12 and 24

Results posted on

2020-08-19

Participant Flow

384 subjects were screened, and 252 subjects completed Screening period. One was lost to follow-up after screening and did not attend any visits for treatment epoch therefore, 251 were recruited to study. 2 subjects died during Screening epoch (1 was reported as discontinued and 1 was reported as a screen failure)

251 subjects entered treatment epoch and were randomized to one of the three bimagrumab dose groups (70 mg, 210 mg and 700 mg) or the placebo group. 1 from the 210 mg group was randomized in error and did not receive study drug. Of the 250 subjects who were randomized and treated, 207 completed the 24 weeks treatment epoch.

Participant milestones

Participant milestones
Measure	Bimagrumab 700 mg bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 210 mg bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 70 mg bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20	Placebo placbo administered via intravenous infusion from Day 1 until Week 20
Epoch: Treatment Epoch STARTED	75	70	34	72
Epoch: Treatment Epoch COMPLETED	64	50	29	64
Epoch: Treatment Epoch NOT COMPLETED	11	20	5	8
Epoch: Post-treatment Follow-up Epoch STARTED	67	54	30	68
Epoch: Post-treatment Follow-up Epoch COMPLETED	63	47	30	66
Epoch: Post-treatment Follow-up Epoch NOT COMPLETED	4	7	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Bimagrumab 700 mg bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 210 mg bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 70 mg bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20	Placebo placbo administered via intravenous infusion from Day 1 until Week 20
Epoch: Treatment Epoch Technical problems	0	0	0	1
Epoch: Treatment Epoch Lost to Follow-up	0	2	0	0
Epoch: Treatment Epoch Withdrawal by Subject	7	8	3	5
Epoch: Treatment Epoch Adverse Event	3	6	1	2
Epoch: Treatment Epoch Death	0	3	1	0
Epoch: Treatment Epoch Non-compliance with treatment	1	1	0	0
Epoch: Post-treatment Follow-up Epoch Withdrawal by Subject	1	3	0	1
Epoch: Post-treatment Follow-up Epoch Lost to Follow-up	1	4	0	0
Epoch: Post-treatment Follow-up Epoch Adverse Event	1	0	0	0
Epoch: Post-treatment Follow-up Epoch Death	1	0	0	1

Baseline Characteristics

Study of Efficacy and Safety of Bimagrumab in Patients After Hip Fracture Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bimagrumab 700 mg n=75 Participants bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 210 mg n=69 Participants bimagrumab 210 mg administered via intravenous infusion from Day 1 until Week 20	Bimagrumab 70 mg n=34 Participants bimagrumad 70 mg administered via intravenous infusion starting Day 1 until Week 20	Placebo n=72 Participants placbo administered via intravenous infusion from Day 1 until Week 20	Total n=250 Participants Total of all reporting groups
Age, Continuous	76.1 years STANDARD_DEVIATION 8.58 • n=99 Participants	74.8 years STANDARD_DEVIATION 8.94 • n=107 Participants	76.1 years STANDARD_DEVIATION 8.59 • n=206 Participants	76.4 years STANDARD_DEVIATION 7.88 • n=7 Participants	75.8 years STANDARD_DEVIATION 8.46 • n=31 Participants
Age, Customized < 65 years	9 Participants n=99 Participants	9 Participants n=107 Participants	4 Participants n=206 Participants	3 Participants n=7 Participants	25 Participants n=31 Participants
Age, Customized 65 - 74 years	22 Participants n=99 Participants	23 Participants n=107 Participants	10 Participants n=206 Participants	27 Participants n=7 Participants	82 Participants n=31 Participants
Age, Customized 75 - 84 years	30 Participants n=99 Participants	26 Participants n=107 Participants	16 Participants n=206 Participants	32 Participants n=7 Participants	104 Participants n=31 Participants
Age, Customized =>85 years	14 Participants n=99 Participants	11 Participants n=107 Participants	4 Participants n=206 Participants	10 Participants n=7 Participants	39 Participants n=31 Participants
Sex: Female, Male Female	54 Participants n=99 Participants	48 Participants n=107 Participants	21 Participants n=206 Participants	53 Participants n=7 Participants	176 Participants n=31 Participants
Sex: Female, Male Male	21 Participants n=99 Participants	21 Participants n=107 Participants	13 Participants n=206 Participants	19 Participants n=7 Participants	74 Participants n=31 Participants
Race/Ethnicity, Customized Caucasian	57 Participants n=99 Participants	58 Participants n=107 Participants	26 Participants n=206 Participants	53 Participants n=7 Participants	194 Participants n=31 Participants
Race/Ethnicity, Customized Black	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Race/Ethnicity, Customized Asian	13 Participants n=99 Participants	8 Participants n=107 Participants	6 Participants n=206 Participants	17 Participants n=7 Participants	44 Participants n=31 Participants
Race/Ethnicity, Customized Other	4 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants	11 Participants n=31 Participants
Race/Ethnicity, Customized Native American	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: baseline, weeks 12 and 24

Population: The Full Analysis Set (FAS) used for all efficacy analyses consists of all randomized patients who received at least one dose of treatment after randomization and had at least one post-dose efficacy assessment. Patients who were randomized in error were excluded. Patients were analyzed according to treatment they were assigned to at randomization.

Outcome measures

Outcome measures
Measure	Bimagrumab 700 mg n=75 Participants Change from baseline in total LBM	Bimagrumab 210 mg n=69 Participants Change from baseline in total LBM	Active Total Efficacy (AT:E) n=144 Participants Change from baseline in total LBM	Placebo n=72 Participants placebo
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 week 12	1.066 kg Standard Error 0.0107	1.052 kg Standard Error 0.0109	1.059 kg Standard Error 0.0096	1.009 kg Standard Error 0.0103
Change From Baseline in Total Lean Body Mass Measured by DXA (Dual-energy X-ray Absorptiometry) at Weeks 12 and 24 week 24	1.064 kg Standard Error 0.0113	1.042 kg Standard Error 0.0115	1.053 kg Standard Error 0.0101	0.996 kg Standard Error 0.0109

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least 1 dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization.

Mixed Model for Repeated Measures (MMRM) of change from baseline in derived gait speed (m/sec) by treatment and visit To assess dose-response relationship of bimagrumab and facilitate an adequate dose selection for future phase III studies, without the need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from a non-effective or minimally effective dose to a dose where maximal efficacy is expected. Original study was initiated with only two doses of bimagrumab, therefore, a lower dose arm of 70mg was added to this study with Amendment 2, changing the randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, bimagrumab 210mg, or bimagrumab 700mg. Since the 70mg dose was expected to show suboptimal efficacy and fewer patients were randomized to this group, it was used only for dose response modelling and not for hypothesis testing. Consequently, no efficacy evaluations for the bimagrumab 70mg Arm were performed

Outcome measures

Outcome measures
Measure	Bimagrumab 700 mg n=75 Participants Change from baseline in total LBM	Bimagrumab 210 mg n=69 Participants Change from baseline in total LBM	Active Total Efficacy (AT:E) n=72 Participants Change from baseline in total LBM	Placebo placebo
Change From Baseline in Gait Speed at Week 24 (Meters/Sec)	0.268 meters per second Standard Error 0.0599	0.350 meters per second Standard Error 0.0617	0.339 meters per second Standard Error 0.0607	—

SECONDARY outcome

Timeframe: Week 24

MMRM change from baseline in total score by treatment \& visit to Week 24 in physical performance measured by Short Physical Performance Battery (SPPB) that evaluates lower extremity function. Score range is 0 (worst performance) to 12 (best) to assess dose-response relationship of bimagrumab \& facilitate adequate dose selection for future phase III studies, without need for supportive data from another dose-response finding study, at least 3 doses were required, ranging from non- or minimally effective dose to a dose where maximal efficacy was expected. Original study was initiated with only 2 doses, therefore, lower 70mg arm was added to this study, changing randomization ratio from 1:1:1 to 2:1:2:2 to either placebo, bimagrumab 70mg, 210mg, or 700mg. Since 70mg dose was expected to show suboptimal efficacy, fewer patients were randomized to this group \& it was used only for dose response modelling \& not hypothesis testing. Consequently, no efficacy evaluation for 70mg were performed

Outcome measures

Outcome measures
Measure	Bimagrumab 700 mg n=75 Participants Change from baseline in total LBM	Bimagrumab 210 mg n=69 Participants Change from baseline in total LBM	Active Total Efficacy (AT:E) n=72 Participants Change from baseline in total LBM	Placebo placebo
Change From Baseline in Short Physical Performance Battery at Weeks 24	2.331 scores on a scale Standard Error 0.5436	3.535 scores on a scale Standard Error 0.5623	2.702 scores on a scale Standard Error 0.5516	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: The Full Analysis Set (FAS) used for all efficacy analyses consisted of all randomized subjects who received at least one dose of investigational drug. Subjects were analyzed according to the treatment they were assigned to at randomization

Group falls rate The frequency of having at least one fall up to Week 48 was summarized by treatment groups Incidence of falls was calculated for each arm up to Week 48. The ratio of these fall rates versus Placebo were calculated and presented as the Falls Rate Ratio. As mentioned in comment 5.1 above, the Falls Rate Ratio for Placebo does not apply because it would entail comparing the group to itself

Outcome measures

Outcome measures
Measure	Bimagrumab 700 mg n=75 Participants Change from baseline in total LBM	Bimagrumab 210 mg n=69 Participants Change from baseline in total LBM	Active Total Efficacy (AT:E) n=34 Participants Change from baseline in total LBM	Placebo n=72 Participants placebo
Incidence of Falls up to Week 48	0.31 Number of Falls per week Interval 0.14 to 0.7	0.45 Number of Falls per week Interval 0.2 to 0.99	0.36 Number of Falls per week Interval 0.13 to 0.97	0.29 Number of Falls per week Interval 0.13 to 0.64

Adverse Events

BYM338 700 mg

Serious events: 15 serious events

Other events: 47 other events

Deaths: 1 deaths

BYM338 210 mg

Serious events: 17 serious events

Other events: 34 other events

Deaths: 3 deaths

BYM338 70 mg

Serious events: 9 serious events

Other events: 15 other events

Deaths: 1 deaths

AT:S

Serious events: 41 serious events

Other events: 96 other events

Deaths: 5 deaths

Placebo

Serious events: 9 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	BYM338 700 mg n=75 participants at risk bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20	BYM338 210 mg n=69 participants at risk bimagrumab 210mg administered via intravenous infusion from Day 1 until Week 20	BYM338 70 mg n=34 participants at risk bimagrumab 70 mg via i.v. infusion	AT:S n=178 participants at risk Active Total Safety	Placebo n=72 participants at risk placebo administered via intravenous infusion from Day 1 until Week 20
Blood and lymphatic system disorders Anaemia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Blood and lymphatic system disorders Leukocytosis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Cardiac disorders Atrial fibrillation	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.7% 3/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Cardiac disorders Cardiac failure	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Cardiac disorders Cardiac failure congestive	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Eye disorders Retinal haemorrhage	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Abdominal pain	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Diarrhoea	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Duodenogastric reflux	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Dyspepsia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Gastrointestinal disorders Haematochezia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
General disorders Multiple organ dysfunction syndrome	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
General disorders Oedema peripheral	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
General disorders Pyrexia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Hepatobiliary disorders Cholecystitis acute	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Hepatobiliary disorders Cholelithiasis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Bronchitis	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.7% 3/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Diverticulitis	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Empyema	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Enterobacter infection	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Erysipelas	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Escherichia urinary tract infection	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Gastroenteritis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Peritonitis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Pneumonia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.1% 2/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Salpingo-oophoritis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Septic shock	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Urinary tract infection	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Urosepsis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Hip fracture	2.7% 2/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.1% 2/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Lumbar vertebral fracture	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Radius fracture	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Spinal fracture	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Metabolism and nutrition disorders Hyponatraemia	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Osteoarthritis	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Nervous system disorders Cerebral infarction	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Nervous system disorders Cerebrovascular accident	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Nervous system disorders Transient ischaemic attack	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Product Issues Device breakage	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Product Issues Device dislocation	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Product Issues Device extrusion	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Psychiatric disorders Depression	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Renal and urinary disorders Acute kidney injury	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.7% 3/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.1% 2/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Deep vein thrombosis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Haematoma	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Hypertension	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Hypotension	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Varicose vein	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.56% 1/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks

Other adverse events

Other adverse events
Measure	BYM338 700 mg n=75 participants at risk bimagrumab 700mg administered via intravenous infusion from Day 1 until Week 20	BYM338 210 mg n=69 participants at risk bimagrumab 210mg administered via intravenous infusion from Day 1 until Week 20	BYM338 70 mg n=34 participants at risk bimagrumab 70 mg via i.v. infusion	AT:S n=178 participants at risk Active Total Safety	Placebo n=72 participants at risk placebo administered via intravenous infusion from Day 1 until Week 20
Gastrointestinal disorders Diarrhoea	9.3% 7/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.8% 4/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	6.2% 11/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
General disorders Oedema peripheral	12.0% 9/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	4.3% 3/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	7.3% 13/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.6% 4/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Bronchitis	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.7% 3/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Nasopharyngitis	6.7% 5/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	4.5% 8/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Infections and infestations Urinary tract infection	10.7% 8/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	4.3% 3/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	7.3% 13/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Contusion	4.0% 3/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.2% 4/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	6.9% 5/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Injury, poisoning and procedural complications Fall	18.7% 14/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	17.4% 12/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	17.6% 6/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	18.0% 32/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	18.1% 13/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Investigations Weight decreased	5.3% 4/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.8% 4/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.1% 9/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.1% 2/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Arthralgia	10.7% 8/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	8.7% 6/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	14.7% 5/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	10.7% 19/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	6.9% 5/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Back pain	5.3% 4/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	7.2% 5/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 1/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.6% 10/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 2/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Muscle spasms	16.0% 12/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	24.6% 17/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	17.4% 31/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	8.3% 6/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Musculoskeletal and connective tissue disorders Pain in extremity	2.7% 2/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 5/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	1.4% 1/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Nervous system disorders Cognitive disorder	1.3% 1/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.8% 4/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 5/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Skin and subcutaneous tissue disorders Rash	4.0% 3/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.8% 5/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	0.00% 0/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks
Vascular disorders Hypertension	4.0% 3/75 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	2.9% 2/69 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.9% 2/34 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	3.9% 7/178 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks	5.6% 4/72 • AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 48 weeks. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 48 weeks All cause mortality (on-treatment deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 48 weeks

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 (862) 778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e.; data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER