Trial Outcomes & Findings for Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (NCT NCT02345070)

Last Updated: 2022-03-24

Results Overview

FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

327 participants

Primary outcome timeframe

Baseline, Week 52

Results posted on

2022-03-24

Participant Flow

The study was conducted at 101 active centers in 19 countries. A total of 652 participants were screened between May 2015 and May 2016, of whom, 327 participants were randomized in 1:1:1 ratio to placebo: SAR156597 200 milligram (mg) once every 2 weeks (q2w): SAR156597 200 mg once every week (qw).

Participants were stratified at the moment of randomization according to background therapy (participants with background anti-fibrotic therapy with either pirfenidone or nintedanib versus participants without background anti-fibrotic therapy).

Participant milestones

Participant milestones
Measure	Placebo qw Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Overall Study STARTED	110	109	108
Overall Study Treated	109	108	108
Overall Study COMPLETED	90	98	85
Overall Study NOT COMPLETED	20	11	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo qw Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Overall Study Adverse Event	12	8	16
Overall Study Poor compliance to protocol	2	0	0
Overall Study Other than specified above	6	3	7

Baseline Characteristics

Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo qw n=110 Participants Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=109 Participants Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=108 Participants Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.	Total n=327 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.6 • n=5 Participants	67.4 years STANDARD_DEVIATION 7.2 • n=7 Participants	68.0 years STANDARD_DEVIATION 7.6 • n=5 Participants	68.1 years STANDARD_DEVIATION 7.8 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	32 Participants n=7 Participants	27 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	77 Participants n=7 Participants	81 Participants n=5 Participants	246 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants	104 Participants n=7 Participants	99 Participants n=5 Participants	308 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: Modified intent-to-treat (mITT) population: All participants who received at least 1 study injection, had valid baseline percent predicted FVC measurement, and had at least 1 post-baseline percent predicted FVC measurement. Here, 'Overall number of participants analyzed' = participants with available data for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo qw n=81 Participants Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=89 Participants Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=75 Participants Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52	-5.81 percent predicted FVC Standard Error 0.74	-5.24 percent predicted FVC Standard Error 0.73	-6.31 percent predicted FVC Standard Error 0.75

SECONDARY outcome

Timeframe: From randomization to disease progression (up to Week 52)

Population: Analysis was performed on mITT population.

Disease progression was defined as the time from randomization to the first occurrence of any of the following events: decrease in absolute percent predicted FVC greater than or equal to (\>=) 10%, decrease in absolute percent predicted Carbon monoxide diffusing lung capacity \>=15%, lung transplant, or death. The median time to disease progression was not estimated because the number of occurrence of events was too low in the SAR156597 200 mg arms.

Outcome measures

Outcome measures
Measure	Placebo qw n=109 Participants Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=108 Participants Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=108 Participants Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52	0.512 probability of disease progression	0.460 probability of disease progression	0.537 probability of disease progression

SECONDARY outcome

Timeframe: From randomization up to Week 52

Population: Analysis was performed on mITT population.

All-cause mortality was considered for this outcome measure which was defined as the time from randomization to the date of death. The median time to event was not estimated because the number of all cause mortality was too low in the SAR156597 200 mg arms.

Outcome measures

Outcome measures
Measure	Placebo qw n=109 Participants Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=108 Participants Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=108 Participants Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52	0.09 probability of deaths	0.08 probability of deaths	0.13 probability of deaths

Adverse Events

Placebo qw

Serious events: 26 serious events

Other events: 81 other events

Deaths: 9 deaths

SAR156597 200mg q2w

Serious events: 27 serious events

Other events: 86 other events

Deaths: 6 deaths

SAR156597 200mg qw

Serious events: 46 serious events

Other events: 79 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo qw n=109 participants at risk Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=108 participants at risk Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=108 participants at risk Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Acute coronary syndrome	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Acute right ventricular failure	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Arrhythmia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Atrial fibrillation	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Atrial flutter	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Cardiac failure	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Cardiac failure congestive	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Congestive cardiomyopathy	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Coronary artery stenosis	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Myocardial infarction	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Right ventricular failure	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Cardiac disorders Ventricular fibrillation	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Congenital, familial and genetic disorders Atrial septal defect	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Ileus	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Oesophageal achalasia	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Volvulus	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Death	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Non-cardiac chest pain	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Hepatobiliary disorders Cholangitis	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Hepatobiliary disorders Hepatic congestion	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Hepatobiliary disorders Hepatic mass	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Bronchitis	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Bronchitis bacterial	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Diverticulitis	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Gastroenteritis	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Gastroenteritis norovirus	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Herpes zoster	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Influenza	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Lower respiratory tract infection	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Lung infection	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.

Other adverse events
Measure	Placebo qw n=109 participants at risk Participants received one injection of placebo (matched to SAR156597) subcutaneously qw for 52 weeks.	SAR156597 200mg q2w n=108 participants at risk Participants received one injection of SAR156597 200 mg subcutaneously q2w alternating with placebo (matched to SAR156597) for 52 weeks.	SAR156597 200mg qw n=108 participants at risk Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
Gastrointestinal disorders Abdominal pain	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	6.5% 7/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Diarrhoea	14.7% 16/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	21.3% 23/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	11.1% 12/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.7% 4/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	5.6% 6/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Nausea	8.3% 9/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	8.3% 9/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	8.3% 9/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Gastrointestinal disorders Vomiting	5.5% 6/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	7.4% 8/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	5.6% 6/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Asthenia	5.5% 6/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	3.7% 4/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	2.8% 3/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Injection site erythema	2.8% 3/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	6.5% 7/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	9.3% 10/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Injection site haematoma	1.8% 2/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	4.6% 5/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	5.6% 6/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Injection site reaction	5.5% 6/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	10.2% 11/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	9.3% 10/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
General disorders Pyrexia	7.3% 8/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.93% 1/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	0.00% 0/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Bronchitis	11.0% 12/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	16.7% 18/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	9.3% 10/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Lower respiratory tract infection	1.8% 2/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	10.2% 11/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	5.6% 6/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Respiratory tract infection	6.4% 7/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	4.6% 5/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	2.8% 3/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Rhinitis	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	7.4% 8/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Upper respiratory tract infection	11.9% 13/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	9.3% 10/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	7.4% 8/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Urinary tract infection	5.5% 6/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	3.7% 4/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	6.5% 7/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Infections and infestations Viral upper respiratory tract infection	13.8% 15/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	16.7% 18/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	11.1% 12/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Investigations Weight decreased	8.3% 9/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	8.3% 9/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	7.4% 8/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Metabolism and nutrition disorders Decreased appetite	0.92% 1/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	6.5% 7/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	5.6% 6/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	1.9% 2/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Musculoskeletal and connective tissue disorders Back pain	8.3% 9/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	12.0% 13/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	8.3% 9/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Nervous system disorders Headache	6.4% 7/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	4.6% 5/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	8.3% 9/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Cough	11.0% 12/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	20.4% 22/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	16.7% 18/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.1% 11/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	9.3% 10/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	12.0% 13/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	9.2% 10/109 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	10.2% 11/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.	7.4% 8/108 • All Adverse Events (AEs) were collected from signature of the informed consent form up to the end of follow up visit (Week 64) regardless of seriousness or relationship to investigational medicinal product (IMP). Reported AEs and death were treatment-emergent AEs that developed/worsened and deaths that occurred during 'treatment emergent period'. Treatment period was defined as the time from the first administration of IMP to the last administration of IMP + 84 days (i.e., Week 64). Analysis was performed on safety population which included participants who received at least 1 dose or part of a dose of IMP and were analyzed according to the treatment actually received.