Trial Outcomes & Findings for Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise (NCT NCT03353350)

NCT ID: NCT03353350

Last Updated: 2022-01-18

Results Overview

Change from Baseline to Week 30 in HbA1c

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

406 participants

Primary outcome timeframe

Baseline to Week 30

Results posted on

2022-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
30-week Core Treatment Period STARTED	102	100	101	103
30-week Core Treatment Period COMPLETED	80	81	77	81
30-week Core Treatment Period NOT COMPLETED	22	19	24	22
26-week Treatment Extension Period STARTED	80	81	77	81
26-week Treatment Extension Period COMPLETED	75	78	73	67
26-week Treatment Extension Period NOT COMPLETED	5	3	4	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
30-week Core Treatment Period Protocol Violation	1	1	1	0
30-week Core Treatment Period Other: Not related to COVID-19	2	2	2	0
30-week Core Treatment Period Adverse Event	0	4	2	3
30-week Core Treatment Period Withdrawal by Subject	19	12	19	19
26-week Treatment Extension Period Protocol Violation	2	0	0	0
26-week Treatment Extension Period Other: Not related to COVID-19	0	0	1	1
26-week Treatment Extension Period Adverse Event	1	0	0	1
26-week Treatment Extension Period Withdrawal by Subject	2	3	3	12

Baseline Characteristics

Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Total n=406 Participants Total of all reporting groups
Age, Customized <50	22 Participants n=99 Participants	21 Participants n=107 Participants	30 Participants n=206 Participants	21 Participants n=7 Participants	94 Participants n=31 Participants
Age, Customized ≥50 and <65	43 Participants n=99 Participants	46 Participants n=107 Participants	44 Participants n=206 Participants	44 Participants n=7 Participants	177 Participants n=31 Participants
Age, Customized ≥65 and <75	26 Participants n=99 Participants	28 Participants n=107 Participants	20 Participants n=206 Participants	31 Participants n=7 Participants	105 Participants n=31 Participants
Age, Customized ≥75	11 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	7 Participants n=7 Participants	30 Participants n=31 Participants
Sex: Female, Male Female	51 Participants n=99 Participants	45 Participants n=107 Participants	49 Participants n=206 Participants	42 Participants n=7 Participants	187 Participants n=31 Participants
Sex: Female, Male Male	51 Participants n=99 Participants	55 Participants n=107 Participants	52 Participants n=206 Participants	61 Participants n=7 Participants	219 Participants n=31 Participants
Race/Ethnicity, Customized Race : White	90 Participants n=99 Participants	93 Participants n=107 Participants	86 Participants n=206 Participants	92 Participants n=7 Participants	361 Participants n=31 Participants
Race/Ethnicity, Customized Race : Black or African American	10 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants	8 Participants n=7 Participants	37 Participants n=31 Participants
Race/Ethnicity, Customized Race : Asian	2 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	5 Participants n=31 Participants
Race/Ethnicity, Customized Race : Other	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Race/Ethnicity, Customized Race : Multiple	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Race/Ethnicity, Customized Ethnicity : Hispanic or Latino	20 Participants n=99 Participants	20 Participants n=107 Participants	25 Participants n=206 Participants	21 Participants n=7 Participants	86 Participants n=31 Participants
Race/Ethnicity, Customized Ethnicity : Not Hispanic or Latino	82 Participants n=99 Participants	80 Participants n=107 Participants	76 Participants n=206 Participants	82 Participants n=7 Participants	320 Participants n=31 Participants
Region of Enrollment North America	54 participants n=99 Participants	53 participants n=107 Participants	57 participants n=206 Participants	58 participants n=7 Participants	222 participants n=31 Participants
Region of Enrollment Europe	48 participants n=99 Participants	47 participants n=107 Participants	44 participants n=206 Participants	45 participants n=7 Participants	184 participants n=31 Participants
Screening HbA1c	7.98 % STANDARD_DEVIATION 0.85 • n=99 Participants	8.03 % STANDARD_DEVIATION 0.75 • n=107 Participants	8.14 % STANDARD_DEVIATION 0.93 • n=206 Participants	8.07 % STANDARD_DEVIATION 0.91 • n=7 Participants	8.05 % STANDARD_DEVIATION 0.87 • n=31 Participants
Baseline BMI	34.8 kg/m² STANDARD_DEVIATION 7.1 • n=99 Participants	34.4 kg/m² STANDARD_DEVIATION 6.4 • n=107 Participants	33.8 kg/m² STANDARD_DEVIATION 6.6 • n=206 Participants	33.8 kg/m² STANDARD_DEVIATION 6.9 • n=7 Participants	34.2 kg/m² STANDARD_DEVIATION 6.8 • n=31 Participants
Baseline BMI category <30	28 Participants n=99 Participants	28 Participants n=107 Participants	28 Participants n=206 Participants	28 Participants n=7 Participants	112 Participants n=31 Participants
Baseline BMI category ≥30 and <40	52 Participants n=99 Participants	53 Participants n=107 Participants	58 Participants n=206 Participants	60 Participants n=7 Participants	223 Participants n=31 Participants
Baseline BMI category ≥40	22 Participants n=99 Participants	19 Participants n=107 Participants	15 Participants n=206 Participants	14 Participants n=7 Participants	70 Participants n=31 Participants
Baseline BMI category Unknown	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	1 Participants n=31 Participants

PRIMARY outcome

Timeframe: Baseline to Week 30

Change from Baseline to Week 30 in HbA1c

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Change in Glycated Hemoglobin (HbA1c) (%)	-0.46 HbA1c (%) Standard Deviation 1.16	-1.14 HbA1c (%) Standard Deviation 0.96	-1.48 HbA1c (%) Standard Deviation 1.01	-1.59 HbA1c (%) Standard Deviation 1.04

SECONDARY outcome

Timeframe: Baseline to Week 56

Change from Baseline to Week 56 in HbA1c

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Change in HbA1c (%)	-0.52 HbA1c (%) Standard Deviation 1.18	-1.18 HbA1c (%) Standard Deviation 0.79	-1.51 HbA1c (%) Standard Deviation 0.99	-1.51 HbA1c (%) Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline to Week 30

Change from Baseline to Week 30 in FPG

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Change in Fasting Plasma Glucose (FPG)	8.59 FPG (mmol/L) Standard Deviation 2.13	-0.87 FPG (mmol/L) Standard Deviation 3.27	6.84 FPG (mmol/L) Standard Deviation 1.57	6.55 FPG (mmol/L) Standard Deviation 1.30

SECONDARY outcome

Timeframe: Week 30

Number of participants with HbA1c \<7.0% at Week 30

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
HbA1c <7%	26 Participants	60 Participants	66 Participants	76 Participants

SECONDARY outcome

Timeframe: Baseline to Week 30

Change from Baseline to Week 30 in body weight

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Change in Body Weight at Week 30	-1.35 kg Standard Deviation 3.15	-1.01 kg Standard Deviation 3.66	-3.34 kg Standard Deviation 4.19	-3.19 kg Standard Deviation 4.77

SECONDARY outcome

Timeframe: Baseline to Week 56

Change from Baseline to Week 56 in body weight

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=100 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=101 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=103 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Change in Body Weight at Week 56	-1.26 kg Standard Deviation 4.19	-0.94 kg Standard Deviation 4.96	-3.24 kg Standard Deviation 6.42	-1.82 kg Standard Deviation 5.52

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Number of participants with at least 1 hypoglycemic event during treatment period

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=102 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=103 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=99 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Hypoglycemic Participants	2 Participants	10 Participants	14 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Number of hypoglycemic events

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=102 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=103 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=99 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Hypoglycemic Events	2 Number of events	10 Number of events	14 Number of events	14 Number of events

SECONDARY outcome

Timeframe: Baseline to Week 56

Population: Safety population: All participants randomly assigned to IMP and who take at least 1 dose of IMP. Participants were analyzed according to the treatment they actually received.

Number of participants with TEAEs

Outcome measures

Outcome measures
Measure	Placebo n=102 Participants Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=102 Participants Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=103 Participants Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=99 Participants Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Treatment Emergent Adverse Events (TEAEs)	79 Number of Treatment Emergent AEs	80 Number of Treatment Emergent AEs	79 Number of Treatment Emergent AEs	83 Number of Treatment Emergent AEs

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 70 other events

Deaths: 0 deaths

Efpeglenatide 2 mg

Serious events: 11 serious events

Other events: 69 other events

Deaths: 0 deaths

Efpeglenatide 4 mg

Serious events: 6 serious events

Other events: 73 other events

Deaths: 0 deaths

Efpeglenatide 6 mg

Serious events: 6 serious events

Other events: 77 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Sujin Jung

Hanmi Pharmaceutical Co., Ltd.

Phone: +82-2-410-0473

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Placebo n=102 participants at risk Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=102 participants at risk Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=103 participants at risk Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=99 participants at risk Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Infections and infestations Cystitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Epiglottitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Gastroenteritis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Meningitis viral	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Pneumonia	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Pyelonephritis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Sepsis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Metabolism and nutrition disorders Depression	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Psychiatric disorders Panic attack	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Psychiatric disorders Stress	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Nervous system disorders Vertebral artery stenosis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Nervous system disorders Cerebral artery stenosis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Ventricular tachycardia	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Acute myocardial infarction	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Angina unstable	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Atrial fibrillation	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Cardiac failure	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Cardiac failure congestive	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Coronary artery disease	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Coronary artery stenosis	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Cardiac disorders Myocardial infarction	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Gastrointestinal disorders Abdominal pain	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Gastrointestinal disorders Colitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Renal and urinary disorders Renal colic	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Renal and urinary disorders Ureterolithiasis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
General disorders Chest pain	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
General disorders Non-cardiac chest pain	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Foreign body in respiratory tract	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Pneumoconiosis	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • Number of events 1 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.

Other adverse events
Measure	Placebo n=102 participants at risk Matching placebo (Prefilled syringe) administered once weekly for 56 weeks placebo: Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 2 mg n=102 participants at risk Efpeglenatide low dose (Prefilled syringe) administered once weekly for 56 weeks efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 4 mg n=103 participants at risk Efpeglenatide middle dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous	Efpeglenatide 6 mg n=99 participants at risk Efpeglenatide high dose (Prefilled syringe) administered once weekly for 56 weeks (including titration period) efpeglenatide (SAR439977): Pharmaceutical form: solution for injection Route of administration: subcutaneous
Vascular disorders Hot flush	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Vascular disorders Subclavian artery occlusion	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Vascular disorders Deep vein thrombosis	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Vascular disorders Essential hypertension	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Chest injury	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Fall	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Nasopharyngitis	7.8% 8/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	9.8% 10/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	6.8% 7/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	11.1% 11/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Upper respiratory tract infection	6.9% 7/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	4.9% 5/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	6.1% 6/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Viral upper respiratory tract infection	6.9% 7/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	4.9% 5/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	6.1% 6/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Bronchitis	3.9% 4/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.9% 3/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	4.0% 4/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Cystitis	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Influenza	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Sinusitis	5.9% 6/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Urinary tract infection	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Cellulitis	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Fungal skin infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Gastroenteritis	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	2.0% 2/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Gastroenteritis viral	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.9% 2/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Localised infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Lower respiratory tract infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Otitis externa	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Otitis media	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Skin infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Tooth abscess	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Tooth infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.0% 1/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Body tinea	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Campylobacter gastroenteritis	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Chronic sinusitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Conjunctivitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.9% 2/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Ear infection	2.9% 3/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	1.9% 2/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Eyelid infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Gastrointestinal infection	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.97% 1/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Gingivitis	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Herpes zoster	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Hordeolum	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Labyrinthitis	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Lower respiratory tract infection bacterial	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.
Infections and infestations Meningitis viral	0.98% 1/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/102 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/103 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.	0.00% 0/99 • All Adverse Events (AEs), Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs requiring specific monitoring were collected from the date of signing the Informed Consent Form (ICF) until the end of the study, defined by the protocol for that participant as Week 62.