Trial Outcomes & Findings for Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A (NCT NCT03447769)

NCT ID: NCT03447769

Last Updated: 2024-10-09

Results Overview

DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1382 participants
• Primary outcome timeframe: Up to approximately 4 years
• Results posted on: 2024-10-09

Participant Flow

The study was conducted across 290 centers in 41 countries. A total of 1830 subjects were screened of which 1382 participants were randomized to treatment on a 1:1 basis.

1 participant randomized in the canakinumab arm was never treated due to subject decision. The numbers in the patient disposition table correspond to the treatment period.

Participant milestones

Measure	Canakinumab Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Overall Study STARTED	693	689
Overall Study Treated	692	689
Overall Study COMPLETED	414	420
Overall Study NOT COMPLETED	279	269

Reasons for withdrawal

Measure	Canakinumab Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Overall Study Progressive disease	138	148
Overall Study Study terminated by Sponsor	60	44
Overall Study Adverse Event	34	31
Overall Study Patient decision	27	27
Overall Study Protocol deviation	4	6
Overall Study Death	2	7
Overall Study Technical problems	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	13	5

Baseline Characteristics

Brief Title: Study of Efficacy and Safety of Canakinumab as Adjuvant Therapy in Adult Subjects With Stages AJCC/UICC v. 8 II-IIIA and IIIB (T>5cm N2) Completely Resected Non-small Cell Lung Cancer Acronym: CANOPY-A

Baseline characteristics by cohort

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Total n=1382 Participants Total of all reporting groups
Age, Continuous	61.5 Years STANDARD_DEVIATION 8.90 • n=5 Participants	61.6 Years STANDARD_DEVIATION 9.00 • n=7 Participants	61.6 Years STANDARD_DEVIATION 8.95 • n=5 Participants
Sex: Female, Male Female	263 Participants n=5 Participants	257 Participants n=7 Participants	520 Participants n=5 Participants
Sex: Female, Male Male	430 Participants n=5 Participants	432 Participants n=7 Participants	862 Participants n=5 Participants
Race/Ethnicity, Customized White	393 Participants n=5 Participants	391 Participants n=7 Participants	784 Participants n=5 Participants
Race/Ethnicity, Customized Asian	248 Participants n=5 Participants	236 Participants n=7 Participants	484 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	49 Participants n=5 Participants	52 Participants n=7 Participants	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 4 years

Population: Full Analysis Set (FAS) including all participants to whom study treatment was assigned by randomization

DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.

The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Disease Free Survival (DFS) by Local Investigator	35.02 Months Interval 28.55 to NA: Not estimable due to the insufficient number of participants with events	29.73 Months Interval 23.72 to NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 4.3 years

Population: FAS including all participants to whom study treatment was assigned by randomization

Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Overall Survival (OS)	51.12 Months Interval 46.95 to NA = Not estimable due to the insufficient number of participants with events	NA Months NA = Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 4.3 years

Population: Participants to whom study treatment was assigned by randomization with a valid baseline measurement of PD-L1 expression.

Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 ≥1% and <49%, and PD-L1 ≥50%.

Outcome measures

Measure	Canakinumab n=396 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=418 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Overall Survival (OS) in PD-L1 Subgroups PD-L1 <1%	NA Months NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events
Overall Survival (OS) in PD-L1 Subgroups PD-L1 ≥1% and <49%	46.95 Months Interval 22.11 to NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events
Overall Survival (OS) in PD-L1 Subgroups PD-L1 ≥50%	51.12 Months NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: up to approximately 4.3 years

Population: Participants to whom study treatment was assigned by randomization with a valid baseline measurement of CD8 expression

Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.

Outcome measures

Measure	Canakinumab n=429 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=449 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Overall Survival (OS) in CD8 Subgroups CD8 < median	46.95 Months Interval 32.23 to NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events
Overall Survival (OS) in CD8 Subgroups CD8 ≥ median	51.12 Months NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 4.3 years

Population: FAS including all participants to whom study treatment was assigned by randomization

LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Lung Cancer Specific Survival (LCSS)	51.12 Months Interval 44.71 to NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 4 years

Population: Participants to whom study treatment was assigned by randomization with a valid baseline measurement of PD-L1 expression.

DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.

The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.

DFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 <1%, PD-L1 ≥1% and <49%, and PD-L1 ≥50%.

Outcome measures

Measure	Canakinumab n=396 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=418 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups PD-L1 <1%	30.72 Months Interval 23.52 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 23.03 to NA: Not estimable due to the insufficient number of participants with events
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups PD-L1 ≥1% and <49%	30.42 Months Interval 21.42 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 17.05 to NA: Not estimable due to the insufficient number of participants with events
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups PD-L1 ≥50%	46.95 Months Interval 19.45 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 22.31 to NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 4 years

Population: Participants to whom study treatment was assigned by randomization with a valid baseline measurement of CD8 expression

DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence.

The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.

DFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.

Outcome measures

Measure	Canakinumab n=429 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=449 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups CD8 < median	26.58 Months Interval 20.67 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 25.03 to NA: Not estimable due to the insufficient number of participants with events
Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups CD8 ≥ median	46.95 Months Interval 28.81 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 23.89 to NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days

Population: The Pharmacokinetic analysis set (PAS) including all subjects who received at least one dose of canakinumab and provided at least one evaluable PK sample.

Serum concentrations of canakinumab were determinded using an ELISA method.

Outcome measures

Measure	Canakinumab n=664 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Canakinumab Serum Concentrations Cycle 1 Day 1	0 ug/ml Standard Deviation 0	—
Canakinumab Serum Concentrations Cycle 1 Day 8	18.1 ug/ml Standard Deviation 6.53	—
Canakinumab Serum Concentrations Cycle 1 Day 15	16.9 ug/ml Standard Deviation 5.43	—
Canakinumab Serum Concentrations Cycle 2 Day 1	15.0 ug/ml Standard Deviation 4.91	—
Canakinumab Serum Concentrations Cycle 4 Day 1	29.7 ug/ml Standard Deviation 10.3	—
Canakinumab Serum Concentrations Cycle 6 Day 1	34.7 ug/ml Standard Deviation 13.0	—
Canakinumab Serum Concentrations Cycle 9 Day 1	37.1 ug/ml Standard Deviation 14.5	—
Canakinumab Serum Concentrations Cycle 12 Day 1	38.6 ug/ml Standard Deviation 15.5	—

SECONDARY outcome

Timeframe: Baseline

Population: All subjects who received at least one dose of canakinumab

Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline

Outcome measures

Measure	Canakinumab n=692 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline	8 Participants	—

SECONDARY outcome

Timeframe: From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years

Population: All subjects who received at least one dose of canakinumab

Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)

Outcome measures

Measure	Canakinumab n=692 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Canakinumab ADA Incidence	7 Participants	—

SECONDARY outcome

Timeframe: From baseline up to approximately 4 years

Population: FAS including all participants to whom study treatment was assigned by randomization

The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.

The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire Pain	NA Months Interval 35.45 to NA: Not estimable due to the insufficient number of participants with events	NA Months NA: Not estimable due to the insufficient number of participants with events
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire Cough	NA Months Interval 35.06 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 34.99 to NA: Not estimable due to the insufficient number of participants with events
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire Dyspnea	28.88 Months Interval 23.1 to 34.96	34.99 Months Interval 23.13 to NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: From baseline up to approximately 4 years

Population: FAS including all participants to whom study treatment was assigned by randomization

The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.

The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Global health status/QoL	34.99 Months Interval 29.93 to NA: Not estimable due to the insufficient number of participants with events	35.15 Months Interval 35.15 to NA: Not estimable due to the insufficient number of participants with events
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Shortness of breath	NA Months NA: Not estimable due to the insufficient number of participants with events	35.15 Months Interval 34.99 to NA: Not estimable due to the insufficient number of participants with events
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Pain	29.93 Months Interval 28.29 to 35.22	36.44 Months Interval 34.99 to NA: Not estimable due to the insufficient number of participants with events

SECONDARY outcome

Timeframe: From baseline up to approximately 4 years

Population: FAS including all participants to whom study treatment was assigned by randomization

The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms.

The time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Pain	35.15 Months Interval 26.58 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 23.06 to NA: Not estimable due to the insufficient number of participants with events
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Cough	15.44 Months Interval 10.38 to 23.06	15.01 Months Interval 9.69 to NA: Not estimable due to the insufficient number of participants with events
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire Dyspnea	4.17 Months Interval 3.42 to 5.55	4.86 Months Interval 3.48 to 6.97

SECONDARY outcome

Timeframe: From baseline up to approximately 4 years

Population: FAS including all participants to whom study treatment was assigned by randomization

The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms.

The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Global health status/QoL	9.23 Months Interval 7.1 to 11.76	9.07 Months Interval 7.62 to 11.76
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Shortness of breath	29.14 Months Interval 23.03 to NA: Not estimable due to the insufficient number of participants with events	NA Months Interval 23.13 to NA: Not estimable due to the insufficient number of participants with events
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire Pain	5.49 Months Interval 4.21 to 6.9	5.62 Months Interval 4.17 to 7.62

SECONDARY outcome

Timeframe: Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.

Population: All participants to whom study treatment was assigned by randomization with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.

EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems).

The EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)

Outcome measures

Measure	Canakinumab n=643 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=629 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 3	0.0 Score on a scale Standard Deviation 0.11	0.0 Score on a scale Standard Deviation 0.12
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 6	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.12
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 9	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.13
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 12	0.0 Score on a scale Standard Deviation 0.12	0.0 Score on a scale Standard Deviation 0.12
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 15	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.12
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 18	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.13
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 21	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 24	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 27	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 30	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 33	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 36	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 39	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.13
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 42	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 45	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 48	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 51	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 54	0.0 Score on a scale Standard Deviation 0.18	0.1 Score on a scale Standard Deviation 0.12
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 57	0.0 Score on a scale	-0.1 Score on a scale
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 60	-0.2 Score on a scale	-0.1 Score on a scale
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 63	0.0 Score on a scale	—
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Week 69	0.0 Score on a scale	—
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Safety FU 1	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Safety FU 2	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Safety FU 3	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Safety FU 4	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.16
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Safety FU 5	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Efficacy FU 1	0.0 Score on a scale Standard Deviation 0.16	0.0 Score on a scale Standard Deviation 0.14
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Efficacy FU 2	0.0 Score on a scale Standard Deviation 0.15	0.0 Score on a scale Standard Deviation 0.16
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Efficacy FU 3	0.0 Score on a scale Standard Deviation 0.14	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Efficacy FU 4	0.0 Score on a scale Standard Deviation 0.13	0.0 Score on a scale Standard Deviation 0.15
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) Efficacy FU 5	0.0 Score on a scale Standard Deviation 0.10	-0.1 Score on a scale Standard Deviation 0.17
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) 7 days post disease progression	-0.1 Score on a scale Standard Deviation 0.16	-0.1 Score on a scale Standard Deviation 0.22
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L) 28 days post disease progression	-0.1 Score on a scale Standard Deviation 0.18	-0.1 Score on a scale Standard Deviation 0.18

POST_HOC outcome

Timeframe: Pre-treatment: Up to 28 days prior to treatment. On-treatment: Up to approx. 1.5 years. Post-treatment follow-up: Up to approx. 4.3 years

Population: FAS including all participants to whom study treatment was assigned by randomization

Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication.

On-treatment deaths were collected from start of treatment to 130 days after last dose.

Post-treatment follow-up deaths were collected from day 131 after last dose of study treatment to end of study.

Outcome measures

Measure	Canakinumab n=693 Participants Participants receive 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)	Placebo n=689 Participants Participants receive canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
All Collected Deaths Pre-treatment deaths	0 Participants	0 Participants
All Collected Deaths On-treatment deaths	9 Participants	17 Participants
All Collected Deaths Post-treatment follow-up deaths	53 Participants	51 Participants
All Collected Deaths All deaths	62 Participants	68 Participants

Adverse Events

All Participants - Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Canakinumab - On-treatment

Serious events: 141 serious events

Other events: 465 other events

Deaths: 9 deaths

Canakinumab - Post-treatment Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 53 deaths

Placebo - On-treatment

Serious events: 146 serious events

Other events: 455 other events

Deaths: 17 deaths

Placebo - Post-treatment Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 51 deaths

Serious adverse events

Measure	All Participants - Pre-treatment Deaths collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment)	Canakinumab - On-treatment n=692 participants at risk AEs collected during on-treatment period (up to 130 days post-treatment)	Canakinumab - Post-treatment Follow-up Deaths collected in the post-treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period	Placebo - On-treatment n=689 participants at risk AEs collected during on-treatment period (up to 130 days post-treatment)	Placebo - Post-treatment Follow-up Deaths collected in the post-treatment follow-up period (starting from day 131 post-treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Blood and lymphatic system disorders Thrombocytosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Acute coronary syndrome	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Acute myocardial infarction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Angina pectoris	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Atrial fibrillation	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Atrial flutter	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Cardiac arrest	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Cardiac failure	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Cardiac failure congestive	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Cardiac ventricular thrombosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Cardiovascular insufficiency	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Coronary artery disease	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Myocardial infarction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.58% 4/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Myocardial ischaemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Pericarditis constrictive	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Cardiac disorders Supraventricular tachycardia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Ear and labyrinth disorders Vertigo	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Eye disorders Retinal detachment	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Eye disorders Retinal tear	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Eye disorders Rhegmatogenous retinal detachment	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Abdominal hernia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Abdominal pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Colitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Constipation	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Diarrhoea	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Enterocolitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Gastrointestinal haemorrhage	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Gastrointestinal pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Haemorrhoids	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Large intestine polyp	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Lumbar hernia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Pancreatic cyst	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Pancreatitis acute	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Rectal haemorrhage	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Vomiting	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Asthenia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Chest pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Fatigue	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Non-cardiac chest pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Pyrexia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Hepatobiliary disorders Biliary colic	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Hepatobiliary disorders Cholecystitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.44% 3/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Hepatobiliary disorders Cholelithiasis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Hepatobiliary disorders Gallbladder obstruction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Hepatobiliary disorders Hepatitis acute	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Appendicitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Asymptomatic COVID-19	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Bronchitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations COVID-19	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.9% 48/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.0% 48/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations COVID-19 pneumonia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.58% 4/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Cellulitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Coronavirus infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Diverticulitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Empyema	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Endocarditis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Herpes zoster	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Infection parasitic	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Kidney infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Localised infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Lung abscess	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Neutropenic sepsis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Pneumonia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	1.9% 13/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	1.3% 9/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Pneumonia pseudomonal	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Rectal abscess	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Respiratory tract infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Sepsis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Septic shock	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Tuberculosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Urinary tract infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Alcohol poisoning	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Head injury	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Hip fracture	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Ligament rupture	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Procedural pneumothorax	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Radius fracture	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Spinal compression fracture	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Injury, poisoning and procedural complications Toxicity to various agents	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Alanine aminotransferase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Aspartate aminotransferase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations C-reactive protein increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.44% 3/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Electrocardiogram T wave amplitude decreased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Hepatic enzyme increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Influenza A virus test positive	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations SARS-CoV-2 test positive	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Metabolism and nutrition disorders Hypokalaemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Metabolism and nutrition disorders Hyponatraemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Metabolism and nutrition disorders Type 2 diabetes mellitus	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Back pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.44% 3/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Tenosynovitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm swelling	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage 0	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Altered state of consciousness	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Aphasia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Carotid artery occlusion	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Cerebral infarction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Cerebrovascular accident	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.58% 4/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.58% 4/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Epilepsy	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Generalised tonic-clonic seizure	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Ischaemic stroke	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Partial seizures	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Peripheral nerve palsy	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Syncope	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Thrombotic cerebral infarction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Ulnar nerve palsy	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Psychiatric disorders Schizophrenia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Calculus urinary	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Haematuria	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Hydronephrosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Renal colic	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Renal haemorrhage	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Renal and urinary disorders Urinary retention	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Reproductive system and breast disorders Benign prostatic hyperplasia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.44% 3/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Dyspnoea	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	1.0% 7/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Epistaxis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Haemoptysis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Hypoxia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Pleural effusion	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Pneumonitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Pneumothorax	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.43% 3/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Respiratory failure	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.29% 2/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Skin and subcutaneous tissue disorders Dermatitis acneiform	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Skin and subcutaneous tissue disorders Skin ulcer	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Vascular disorders Embolism	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.14% 1/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Vascular disorders Hypertension	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Vascular disorders Peripheral ischaemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.00% 0/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	0.15% 1/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization

Other adverse events

Measure	All Participants - Pre-treatment Deaths collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment)	Canakinumab - On-treatment n=692 participants at risk AEs collected during on-treatment period (up to 130 days post-treatment)	Canakinumab - Post-treatment Follow-up Deaths collected in the post-treatment follow-up period (starting from day 131 post- treatment). No AEs were collected during this period	Placebo - On-treatment n=689 participants at risk AEs collected during on-treatment period (up to 130 days post-treatment)	Placebo - Post-treatment Follow-up Deaths collected in the post-treatment follow-up period (starting from day 131 post-treatment). No AEs were collected during this period
Blood and lymphatic system disorders Anaemia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.6% 46/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.3% 50/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Constipation	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.9% 34/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.1% 42/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Diarrhoea	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	8.2% 57/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.0% 48/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Gastrointestinal disorders Nausea	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.6% 46/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.4% 51/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Asthenia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.8% 47/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.8% 33/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Fatigue	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	10.1% 70/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	8.7% 60/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
General disorders Pyrexia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.0% 28/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.2% 43/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Nasopharyngitis	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.4% 44/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.8% 33/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Infections and infestations Upper respiratory tract infection	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	5.3% 37/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.5% 31/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Alanine aminotransferase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	9.4% 65/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.1% 49/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Amylase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.5% 52/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.4% 51/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Aspartate aminotransferase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.7% 53/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	5.4% 37/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Lipase increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.8% 47/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.8% 47/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Neutrophil count decreased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.5% 45/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	1.9% 13/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations Weight increased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	9.1% 63/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.0% 48/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Investigations White blood cell count decreased	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	5.1% 35/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	2.6% 18/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Arthralgia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	10.7% 74/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	12.8% 88/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Musculoskeletal and connective tissue disorders Back pain	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	8.8% 61/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	8.1% 56/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Headache	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.5% 31/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	8.7% 60/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Nervous system disorders Paraesthesia	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.2% 29/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	6.4% 44/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	12.9% 89/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	15.7% 108/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Respiratory, thoracic and mediastinal disorders Dyspnoea	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	9.7% 67/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	7.3% 50/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Skin and subcutaneous tissue disorders Pruritus	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	5.1% 35/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	4.9% 34/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization
Vascular disorders Hypertension	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	5.1% 35/692 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	3.5% 24/689 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization	— 0/0 • Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years. Treatment-emergent AEs refer to any signs or symptoms observed during the study treatment and up to 130 days after treatment, considering the Safety Set (including participants who received at least one dose of study treatment). All-Cause Mortality analysis encompasses the Full Analysis Set, including all participants to whom study treatment was assigned by randomization

Additional Information

Study director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: novartis.email@novartis.com

Results disclosure agreements

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

Restriction type: OTHER