Trial Outcomes & Findings for Effect of Efpeglenatide on Cardiovascular Outcomes (NCT NCT03496298)

NCT ID: NCT03496298

Last Updated: 2021-10-15

Results Overview

All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100\*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 4076 participants
• Primary outcome timeframe: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)
• Results posted on: 2021-10-15

Participant Flow

The study was conducted at 344 active sites in 28 countries. Overall, 5732 participants were screened between 27 April 2018 and 25 April 2019; of whom 4076 participants were randomized by interactive response technology (1:1:1 ratio) to receive placebo, efpeglenatide 4 milligrams (mg) or efpeglenatide 6 mg. Screen failures were mainly due to inclusion criteria not met.

Randomization was stratified by the current or potential future use of a sodium-glucose co-transporter-2 (SGLT2) inhibitor: current use; potential future use; neither current nor potential future use.

Participant milestones

Measure	Placebo Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).	Efpeglenatide 4 mg Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).	Efpeglenatide 6 mg Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
Overall Study STARTED	1359	1359	1358
Overall Study Randomized and Treated	1358	1358	1357
Overall Study Safety Population	1355	1360	1358
Overall Study COMPLETED	42	36	23
Overall Study NOT COMPLETED	1317	1323	1335

Reasons for withdrawal

Measure	Placebo Participants received placebo (matched to Efpeglenatide) as subcutaneous (SC) injection once weekly up to end of treatment (median duration: 19.8 months).	Efpeglenatide 4 mg Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).	Efpeglenatide 6 mg Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
Overall Study Adverse Event	49	68	79
Overall Study Study terminated by Sponsor	1050	1063	1071
Overall Study Physician decision (other than Adverse event)	12	17	10
Overall Study Withdrawal by Subject	176	154	151
Overall Study Other	29	20	23
Overall Study Randomized and not treated	1	1	1

Baseline Characteristics

Here, 'number analyzed' = participants with available data for the specified baseline measure.

Baseline characteristics by cohort

Measure	Placebo n=1359 Participants Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).	Efpeglenatide 4 mg n=1359 Participants Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).	Efpeglenatide 6 mg n=1358 Participants Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).	Total n=4076 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 8.3 • n=1359 Participants	64.6 years STANDARD_DEVIATION 8.2 • n=1359 Participants	64.7 years STANDARD_DEVIATION 8.2 • n=1358 Participants	64.5 years STANDARD_DEVIATION 8.2 • n=4076 Participants
Sex: Female, Male Female	419 Participants n=1359 Participants	442 Participants n=1359 Participants	483 Participants n=1358 Participants	1344 Participants n=4076 Participants
Sex: Female, Male Male	940 Participants n=1359 Participants	917 Participants n=1359 Participants	875 Participants n=1358 Participants	2732 Participants n=4076 Participants
Race (NIH/OMB) American Indian or Alaska Native	11 Participants n=1359 Participants	8 Participants n=1359 Participants	8 Participants n=1358 Participants	27 Participants n=4076 Participants
Race (NIH/OMB) Asian	98 Participants n=1359 Participants	87 Participants n=1359 Participants	82 Participants n=1358 Participants	267 Participants n=4076 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1359 Participants	1 Participants n=1359 Participants	2 Participants n=1358 Participants	3 Participants n=4076 Participants
Race (NIH/OMB) Black or African American	50 Participants n=1359 Participants	38 Participants n=1359 Participants	55 Participants n=1358 Participants	143 Participants n=4076 Participants
Race (NIH/OMB) White	1162 Participants n=1359 Participants	1192 Participants n=1359 Participants	1180 Participants n=1358 Participants	3534 Participants n=4076 Participants
Race (NIH/OMB) More than one race	4 Participants n=1359 Participants	9 Participants n=1359 Participants	5 Participants n=1358 Participants	18 Participants n=4076 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=1359 Participants	24 Participants n=1359 Participants	26 Participants n=1358 Participants	84 Participants n=4076 Participants
Body Mass Index (BMI)	32.40 kilogram meter per square (kg/m^2) STANDARD_DEVIATION 6.01 • n=1359 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	32.81 kilogram meter per square (kg/m^2) STANDARD_DEVIATION 6.22 • n=1357 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	32.90 kilogram meter per square (kg/m^2) STANDARD_DEVIATION 6.21 • n=1357 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.	32.70 kilogram meter per square (kg/m^2) STANDARD_DEVIATION 6.15 • n=4073 Participants • Here, 'number analyzed' = participants with available data for the specified baseline measure.

PRIMARY outcome

Timeframe: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Population: Analysis was performed on intent-to-treat (ITT) population. Data for this outcome measure (OM) was planned to be collected and analyzed for pooled population of participants who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

All MACE positively adjudicated by the clinical endpoint committee (CEC) were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal myocardial infarction (MI), and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

Outcome measures

Measure	Efpeglenatide 4 mg+6 mg n=2717 Participants Included all participants who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).	Placebo n=1359 Participants Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
Time to First Occurrence of Major Adverse Cardiovascular Events (MACE): Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event - Non-Inferiority Analysis	3.9 events per 100 participant-years Interval 3.4 to 4.5	5.3 events per 100 participant-years Interval 4.4 to 6.3

SECONDARY outcome

Timeframe: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Population: Analysis was performed on ITT population. Data for this OM was planned to be collected and analyzed for pooled population of participants who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

All MACE positively adjudicated by the CEC were used in the analysis of the composite outcome of first occurrence to CV death, non-fatal MI, and non-fatal stroke. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

Outcome measures

Measure	Efpeglenatide 4 mg+6 mg n=2717 Participants Included all participants who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).	Placebo n=1359 Participants Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
Time to First Occurrence of Major Adverse Cardiovascular Events: Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular Event - Superiority Analysis	3.9 events per 100 participant-years Interval 3.4 to 4.5	5.3 events per 100 participant-years Interval 4.4 to 6.3

SECONDARY outcome

Timeframe: From Day 1 until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 31.5 months)

Population: Analysis was performed on ITT population. Data for this OM was planned to be collected and analyzed for pooled population of participants who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

All MACE positively adjudicated by the CEC were used in the analysis of the expanded outcome of first occurrence to CV death (including fatal MI and fatal stroke), non-fatal MI, non-fatal stroke, coronary revascularization or hospitalization for unstable angina. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of MACE over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported. Data analysis was also performed independently by external steering committee for the publication.

Outcome measures

Measure	Efpeglenatide 4 mg+6 mg n=2717 Participants Included all participants who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).	Placebo n=1359 Participants Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
Time to First Occurrence of the Expanded Major Adverse Cardiovascular Events Composite Events: Event Rate Per 100 Participant-years for First Occurrence of Expanded Major Cardiovascular Event	5.4 events per 100 participant-years	6.8 events per 100 participant-years

SECONDARY outcome

Timeframe: From Day 1 until the confirmed occurrence of composite renal endpoint (maximum duration: up to 31.5 months)

Population: Analysis was performed on ITT population. Data for this OM was planned to be collected and analyzed for pooled population of participants who received Efpeglenatide (at any dose: 4 mg and 6 mg) as pre-specified in the protocol.

Composite renal endpoint included the following: incident macroalbuminuria (defined as urinary albumin-to-creatinine ratio of greater than (>) 300, as measured in mg of albumin to grams of creatinine, or >33.9, as measured in mg of albumin to millimoles of creatinine), plus an increase in urinary albumin-to-creatinine ratio of at least 30% from baseline, a sustained decrease in estimated glomerular filtration rate (eGFR) of at least 40% for 30 days or more, renal-replacement therapy for 90 days or more, and a sustained eGFR of less than 15 ml per minute per 1.73 m^2 for 30 days or more. Kaplan-Meier curves of the cumulative event rate by treatment groups were used to depict the first occurrence of renal endpoint over time. The event rate per 100 participant-years (calculated by 100*number of participants with events/sum of time at risk (days) over all participants/365.25) measured in terms of number of events per 100 participant-years was reported.

Outcome measures

Measure	Efpeglenatide 4 mg+6 mg n=2717 Participants Included all participants who received either Efpeglenatide 4 mg or 6 mg as SC injection once weekly up to end of treatment (median duration: 19.9 months).	Placebo n=1359 Participants Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).
Time to First Occurrence of Composite Renal Endpoint: Event Rate Per 100 Participant-years for First Occurrence of Composite Renal Endpoint	7.7 events per 100 participant-years Interval 6.9 to 8.6	11.6 events per 100 participant-years Interval 10.2 to 13.1

Adverse Events

Placebo

Serious events: 298 serious events

Other events: 151 other events

Deaths: 49 deaths

Efpeglenatide 4 mg

Serious events: 312 serious events

Other events: 348 other events

Deaths: 40 deaths

Efpeglenatide 6 mg

Serious events: 275 serious events

Other events: 342 other events

Deaths: 25 deaths

Serious adverse events

Measure	Placebo n=1355 participants at risk Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).	Efpeglenatide 4 mg n=1360 participants at risk Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).	Efpeglenatide 6 mg n=1358 participants at risk Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
Blood and lymphatic system disorders Acquired Haemophilia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Anaemia	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Anaemia Vitamin B12 Deficiency	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Blood Loss Anaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Hypochromic Anaemia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Acute Left Ventricular Failure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Acute Myocardial Infarction	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Angina Pectoris	0.74% 10/1355 • Number of events 13 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.59% 8/1360 • Number of events 8 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	1.3% 17/1358 • Number of events 17 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Angina Unstable	1.7% 23/1355 • Number of events 29 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	1.5% 20/1360 • Number of events 23 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.74% 10/1358 • Number of events 11 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Aortic Valve Stenosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Arrhythmia Supraventricular	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Arteriosclerosis Coronary Artery	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Atrial Fibrillation	0.89% 12/1355 • Number of events 16 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	1.1% 15/1360 • Number of events 17 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.88% 12/1358 • Number of events 13 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Atrial Flutter	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Atrial Tachycardia	0.07% 1/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Atrioventricular Block	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Atrioventricular Block Complete	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Bradyarrhythmia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Bradycardia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Bundle Branch Block Left	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Arrest	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Discomfort	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Failure	0.89% 12/1355 • Number of events 12 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Failure Acute	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Failure Chronic	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Failure Congestive	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiac Valve Disease	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardio-Respiratory Arrest	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiogenic Shock	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiomyopathy	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiomyopathy Acute	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Cardiovascular Insufficiency	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Coronary Artery Disease	0.74% 10/1355 • Number of events 11 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	1.0% 14/1360 • Number of events 14 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1358 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Coronary Artery Occlusion	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Coronary Artery Stenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Left Ventricular Dysfunction	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Left Ventricular Failure	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Mitral Valve Incompetence	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Myocardial Infarction	0.66% 9/1355 • Number of events 10 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.44% 6/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Myocardial Ischaemia	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Pericarditis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Sinus Node Dysfunction	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Sinus Tachycardia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Supraventricular Tachycardia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Tachycardia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Ventricular Arrhythmia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Cardiac disorders Ventricular Tachycardia	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Congenital, familial and genetic disorders Hypertrophic Cardiomyopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Deafness Neurosensory	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Deafness Unilateral	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Meniere's Disease	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Vertigo	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Ear and labyrinth disorders Vestibular Disorder	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Endocrine disorders Goitre	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Endocrine disorders Thyroid Mass	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Endocrine disorders Thyroiditis Chronic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Cataract	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Eyelid Ptosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Open Angle Glaucoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Retinal Artery Embolism	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Retinal Detachment	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Eye disorders Vitreous Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Abdominal Incarcerated Hernia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Abdominal Pain	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Abdominal Strangulated Hernia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Ascites	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Chronic Gastritis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Colitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Colitis Ischaemic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Diabetic Gastroparesis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Diarrhoea	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Diverticulum	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Duodenal Ulcer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Duodenitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Dyspepsia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Faecaloma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastritis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastritis Erosive	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastrointestinal Perforation	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Gastrooesophageal Sphincter Insufficiency	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Ileus	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Inguinal Hernia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Intestinal Obstruction	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Intra-Abdominal Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Large Intestine Polyp	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Mallory-Weiss Syndrome	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Mechanical Ileus	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Mesenteric Artery Stenosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Nausea	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Obstructive Pancreatitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Oesophageal Disorder	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Oesophagitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Palatal Disorder	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Pancreatitis Acute	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Pancreatitis Chronic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Peptic Ulcer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Subileus	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Umbilical Hernia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Varices Oesophageal	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Vomiting	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Accidental Death	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Asthenia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Cardiac Death	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Chest Pain	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Death	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Fatigue	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Impaired Healing	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Non-Cardiac Chest Pain	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.44% 6/1360 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1358 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Peripheral Swelling	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Pyrexia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Sudden Cardiac Death	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Sudden Death	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Vascular Stent Stenosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
General disorders Vascular Stent Thrombosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Autoimmune Hepatitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Cholecystitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Cholelithiasis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Cholestasis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Chronic Hepatitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Hepatic Cirrhosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Hepatic Cyst	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Hyperplastic Cholecystopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Hepatobiliary disorders Jaundice	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Immune system disorders Drug Hypersensitivity	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Immune system disorders Hypersensitivity	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Abscess Soft Tissue	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Appendicitis	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Arthritis Bacterial	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Atypical Pneumonia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Bronchitis	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Bronchitis Bacterial	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Covid-19	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1358 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Covid-19 Pneumonia	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.51% 7/1360 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.44% 6/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Campylobacter Gastroenteritis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Cellulitis	0.44% 6/1355 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Cholangitis Infective	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Chronic Sinusitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Cystitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Dermatitis Infected	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Diabetic Foot Infection	0.07% 1/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Diabetic Gangrene	0.15% 2/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Disseminated Tuberculosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Diverticulitis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Enterococcal Bacteraemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Escherichia Bacteraemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Escherichia Sepsis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Gangrene	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Gastroenteritis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.44% 6/1358 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Gastroenteritis Salmonella	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Gastroenteritis Viral	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Gastrointestinal Infection	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Groin Abscess	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations H1n1 Influenza	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Hepatitis C	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Hepatitis E	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Herpes Zoster Infection Neurological	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Influenza	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Joint Abscess	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Klebsiella Sepsis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Large Intestine Infection	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Laryngitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Localised Infection	0.30% 4/1355 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Mastoiditis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Mediastinitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Oesophageal Abscess	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Osteomyelitis	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Peritonitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pilonidal Cyst	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia	1.1% 15/1355 • Number of events 16 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	1.0% 14/1360 • Number of events 14 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.66% 9/1358 • Number of events 9 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Bacterial	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Influenzal	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Klebsiella	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Mycoplasmal	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Staphylococcal	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pneumonia Viral	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Postoperative Wound Infection	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pyelonephritis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pyelonephritis Acute	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Pyelonephritis Chronic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Renal Cyst Infection	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Salpingitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Scrub Typhus	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Sepsis	0.66% 9/1355 • Number of events 9 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Septic Shock	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Sinusitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Skin Infection	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Soft Tissue Infection	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Staphylococcal Bacteraemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Staphylococcal Sepsis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Subcutaneous Abscess	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Suspected Covid-19	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Tuberculosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Tuberculosis Gastrointestinal	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Urinary Tract Infection	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.51% 7/1360 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Urinary Tract Infection Enterococcal	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Urosepsis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Vulval Abscess	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Wound Infection	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Infections and infestations Wound Sepsis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Accidental Overdose	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Anastomotic Complication	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Ankle Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Arterial Bypass Occlusion	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Arterial Bypass Stenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Brachial Plexus Injury	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Fall	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Fibula Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Heat Exhaustion	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Hip Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Joint Injury	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Lower Limb Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Meniscus Injury	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Neck Injury	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Periprosthetic Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Postoperative Respiratory Failure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Procedural Site Reaction	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Road Traffic Accident	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Scapula Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Skin Laceration	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Spinal Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Stomal Hernia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Subdural Haematoma	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Tibia Fracture	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Upper Limb Fracture	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Vascular Graft Thrombosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Alanine Aminotransferase Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Anticoagulation Drug Level Above Therapeutic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Aspartate Aminotransferase Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Blood Glucose Increased	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Blood Pressure Decreased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Blood Pressure Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Heart Rate Abnormal	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Hepatic Enzyme Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Lipase Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Liver Function Test Abnormal	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Plasminogen Activator Inhibitor Increased	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Troponin Increased	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Investigations Weight Decreased	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Dehydration	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.44% 6/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Diabetes Mellitus	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Food Intolerance	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Gout	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hyperglycaemia	0.37% 5/1355 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.59% 8/1360 • Number of events 9 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hyperglycaemic Hyperosmolar Nonketotic Syndrome	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypoglycaemia	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.59% 8/1360 • Number of events 8 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hyponatraemia	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypovolaemia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Lactic Acidosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Metabolic Acidosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Back Pain	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Bursitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Exostosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Groin Pain	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Meniscal Degeneration	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Osteochondritis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Spinal Pain	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Colon	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Scrotum	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm Of Skin	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-Cell Lymphoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma Stage Iv	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial Cancer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Liver	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Lung	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour Of The Lung Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer Stage Iv	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma Stage Iv	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Recurrent	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic Adenoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid Cancer Metastatic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma Stage Iv	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Oncocytoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal Cord Neoplasm	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of The Oral Cavity	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Brain Injury	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Carotid Artery Disease	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Carotid Artery Stenosis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 6 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Carotid Sinus Syndrome	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Cerebrovascular Accident	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Cerebrovascular Disorder	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Cerebrovascular Insufficiency	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Cervical Radiculopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Cervicobrachial Syndrome	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Diabetic Hyperosmolar Coma	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Dizziness	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Encephalopathy	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Facial Paralysis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Haemorrhagic Stroke	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Headache	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Hepatic Encephalopathy	0.07% 1/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Hydrocephalus	0.07% 1/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Hypoglycaemic Encephalopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Hypoglycaemic Seizure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Hypoglycaemic Unconsciousness	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Ischaemic Stroke	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Lacunar Stroke	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Lumbosacral Radiculopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Metabolic Encephalopathy	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Myasthenia Gravis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Myelopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Neuropathy Peripheral	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Paraesthesia	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Presyncope	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Radiculopathy	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Sciatica	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Seizure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Senile Dementia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Syncope	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.52% 7/1358 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Toxic Encephalopathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Transient Ischaemic Attack	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Vith Nerve Paralysis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Nervous system disorders Vocal Cord Paresis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Product Issues Device Fastener Issue	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Product Issues Device Lead Issue	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Product Issues Device Loosening	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Psychiatric disorders Delirium	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Psychiatric disorders Depression	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Psychiatric disorders Major Depression	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Psychiatric disorders Panic Attack	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Psychiatric disorders Suicidal Ideation	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Acute Kidney Injury	0.66% 9/1355 • Number of events 9 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.74% 10/1360 • Number of events 10 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.74% 10/1358 • Number of events 11 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Chronic Kidney Disease	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Diabetic Nephropathy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Haematuria	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Hydronephrosis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Nephrolithiasis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Nephropathy Toxic	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Renal Colic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Renal Failure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Renal Impairment	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Tubulointerstitial Nephritis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Ureterolithiasis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Urinary Bladder Polyp	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Renal and urinary disorders Urinary Retention	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Cervical Polyp	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Endometriosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Prostatic Atrophy	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Reproductive system and breast disorders Prostatitis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.07% 1/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 7 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleurocutaneous Fistula	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Dermal Cyst	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Diabetic Foot	0.59% 8/1355 • Number of events 9 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.59% 8/1360 • Number of events 8 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1358 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Ischaemic Skin Ulcer	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Skin and subcutaneous tissue disorders Skin Ulcer	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.37% 5/1360 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Aortic Stenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Arterial Haemorrhage	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Arterial Occlusive Disease	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Arteriosclerosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Deep Vein Thrombosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Diabetic Vascular Disorder	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Dry Gangrene	0.15% 2/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Essential Hypertension	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Extremity Necrosis	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Hypertension	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Hypertensive Crisis	0.30% 4/1355 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.22% 3/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Hypertensive Emergency	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Hypotension	0.15% 2/1355 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.29% 4/1360 • Number of events 4 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Intermittent Claudication	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Lymphoedema	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Orthostatic Hypotension	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Arterial Occlusive Disease	0.59% 8/1355 • Number of events 8 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.51% 7/1360 • Number of events 8 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.74% 10/1358 • Number of events 10 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Artery Occlusion	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Artery Stenosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Artery Thrombosis	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Circulatory Failure	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Embolism	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1358 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Ischaemia	0.22% 3/1355 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1358 • Number of events 3 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Peripheral Vascular Disorder	0.37% 5/1355 • Number of events 5 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.15% 2/1360 • Number of events 2 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Thrombosis	0.07% 1/1355 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1360 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Vascular disorders Venous Thrombosis Limb	0.00% 0/1355 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.07% 1/1360 • Number of events 1 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	0.00% 0/1358 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.

Other adverse events

Measure	Placebo n=1355 participants at risk Participants received placebo (matched to Efpeglenatide) as SC injection once weekly up to end of treatment (median duration: 19.8 months).	Efpeglenatide 4 mg n=1360 participants at risk Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks then 4 mg per week up to end of treatment (median duration: 19.9 months).	Efpeglenatide 6 mg n=1358 participants at risk Participants received Efpeglenatide as SC injection 2 mg per week for 4 weeks, then 4 mg per week for 4 weeks and then 6 mg per week up to end of treatment (median duration: 20 months).
Gastrointestinal disorders Diarrhoea	4.7% 64/1355 • Number of events 69 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	8.5% 116/1360 • Number of events 139 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	8.6% 117/1358 • Number of events 153 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Nausea	3.8% 51/1355 • Number of events 60 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	14.4% 196/1360 • Number of events 282 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	12.3% 167/1358 • Number of events 194 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Gastrointestinal disorders Vomiting	1.3% 18/1355 • Number of events 19 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	6.2% 85/1360 • Number of events 106 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	5.5% 75/1358 • Number of events 95 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Decreased Appetite	1.1% 15/1355 • Number of events 16 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	5.0% 68/1360 • Number of events 74 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	5.7% 77/1358 • Number of events 80 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.
Metabolism and nutrition disorders Hypoglycaemia	2.7% 37/1355 • Number of events 81 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	5.4% 73/1360 • Number of events 159 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.	3.9% 53/1358 • Number of events 97 • From time of first injection of investigational medicinal product (IMP) to the last injection of IMP + 30 days (i.e., up to maximum duration of 31.5 months). Reported adverse events (AEs) and deaths were treatment-emergent AEs (TEAEs), which was defined as AEs that developed/worsened/became serious during the TEAE period (defined as time from first injection of IMP to the last injection of IMP + 30 days). Safety population: all randomized participants who had received at least 1 dose of double-blind treatment, regardless of the amount of treatment administered, analyzed according to treatment actually received.

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