Trial Outcomes & Findings for A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035) (NCT NCT05093933)

NCT ID: NCT05093933

Last Updated: 2025-12-19

Results Overview

The time to first occurrence of the composite endpoint of CV death or HF hospitalization was defined as the time from randomization to the first event of CV death or HF hospitalization. Randomized participants without a HF hospitalization or CV death event at the time of analysis were censored at the last available information, when the protocol pre-specified number of total CV death events was achieved (primary completion analysis data cutoff), or the date of their non-CV death, whichever occurred first. Events were confirmed by a clinical events committee (CEC). Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death or HF hospitalization event per 100 patient-years at risk is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6106 participants
• Primary outcome timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)
• Results posted on: 2025-12-19

Participant Flow

Of 10923 participants screened, 6106 participants were randomized in a 1:1 ratio to receive either vericiguat or matching placebo. One participant was randomized in the study at 2 different clinical study sites. Due to double enrolment and study site noncompliance with Good Clinical Practice (GCP), this participant was excluded from all efficacy and safety analyses. Results are presented based on 6105 randomized participants.

Participant milestones

Measure	Vericiguat Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Overall Study STARTED	3053	3052
Overall Study Treated	3049	3049
Overall Study COMPLETED	2648	2571
Overall Study NOT COMPLETED	405	481

Reasons for withdrawal

Measure	Vericiguat Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Overall Study Death	372	434
Overall Study Lost to Follow-up	13	16
Overall Study Physician Decision	0	2
Overall Study Sponsor Decision	1	3
Overall Study Withdrawal by Guardian	1	1
Overall Study Withdrawal by Subject	18	25

Baseline Characteristics

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

Baseline characteristics by cohort

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Total n=6105 Participants Total of all reporting groups
Age, Continuous	67.1 Years STANDARD_DEVIATION 11.0 • n=8 Participants	67.0 Years STANDARD_DEVIATION 11.0 • n=6 Participants	67.0 Years STANDARD_DEVIATION 11.0 • n=6 Participants
Sex: Female, Male Female	727 Participants n=8 Participants	713 Participants n=6 Participants	1440 Participants n=6 Participants
Sex: Female, Male Male	2326 Participants n=8 Participants	2339 Participants n=6 Participants	4665 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	968 Participants n=8 Participants	953 Participants n=6 Participants	1921 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2044 Participants n=8 Participants	2068 Participants n=6 Participants	4112 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	41 Participants n=8 Participants	31 Participants n=6 Participants	72 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	159 Participants n=8 Participants	142 Participants n=6 Participants	301 Participants n=6 Participants
Race (NIH/OMB) Asian	383 Participants n=8 Participants	363 Participants n=6 Participants	746 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=8 Participants	7 Participants n=6 Participants	11 Participants n=6 Participants
Race (NIH/OMB) Black or African American	251 Participants n=8 Participants	218 Participants n=6 Participants	469 Participants n=6 Participants
Race (NIH/OMB) White	1942 Participants n=8 Participants	1992 Participants n=6 Participants	3934 Participants n=6 Participants
Race (NIH/OMB) More than one race	313 Participants n=8 Participants	330 Participants n=6 Participants	643 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
New York Heart Association (NYHA) Functional Classification (FC) of Heart Failure NYHA Class II	2411 Participants n=8 Participants	2411 Participants n=6 Participants	4822 Participants n=6 Participants
New York Heart Association (NYHA) Functional Classification (FC) of Heart Failure NYHA Class III/IV	642 Participants n=8 Participants	641 Participants n=6 Participants	1283 Participants n=6 Participants

PRIMARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

The time to first occurrence of the composite endpoint of CV death or HF hospitalization was defined as the time from randomization to the first event of CV death or HF hospitalization. Randomized participants without a HF hospitalization or CV death event at the time of analysis were censored at the last available information, when the protocol pre-specified number of total CV death events was achieved (primary completion analysis data cutoff), or the date of their non-CV death, whichever occurred first. Events were confirmed by a clinical events committee (CEC). Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death or HF hospitalization event per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years	11.3 Pts. with event/100 patient-yrs at risk	12.2 Pts. with event/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

Time to CV death was defined as the time from randomization to CV death. Randomized participants without a CV death at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their non-CV death, whichever occurred first. CV deaths were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death event per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to CV Death: Participants With an Event Per 100 Patient-Years	5.7 Pts. with event/100 patient-yrs at risk	6.8 Pts. with event/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

Time to first occurrence of HF hospitalization was defined as the time from randomization to the first event of HF hospitalization. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an HF hospitalization event per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years	7.2 Pts. with event/100 patient-yrs at risk	7.6 Pts. with event/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

Time to total HF hospitalizations was defined as the time from randomization to all HF hospitalization events, including time to first event and time increments between events. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of total HF hospitalization events per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years	10.7 Total events/100 patient-yrs at risk	11.8 Total events/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

The time to first occurrence of the composite endpoint of all-cause mortality or HF hospitalization was defined as the time from randomization to the first event of all-cause mortality or HF hospitalization. Randomized participants without an all-cause mortality or HF hospitalization event at the time of analysis were censored at the last available information or when the protocol pre-specified number of total CV death events is achieved (primary analysis database cutoff), whichever occurred first. Events were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality or HF hospitalization event per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years	12.7 Pts. with event/100 patient-yrs at risk	13.9 Pts. with event/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who had GCP-compliant data collected.

Time to all-cause mortality was defined as the time from randomization to all-cause mortality. Randomized participants without an all-cause mortality event at the time of analysis were censored at their last available information or when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), whichever occurred first. All-cause mortality was confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality event per 100 patient-years at risk is presented.

Outcome measures

Measure	Vericiguat n=3053 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3052 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years	7.3 Pts. with event/100 patient-yrs at risk	8.6 Pts. with event/100 patient-yrs at risk

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Selected NSAEs are defined as nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or Coronavirus Disease 2019 (COVID-19) disease-related AEs. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more selected NSAEs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs)	19.7 Percentage of participants	16.9 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical events as determined by the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more SAEs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)	23.5 Percentage of participants	24.6 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

ECIs were determined and reported based on the clinical judgment of the investigator. As pre-specified in the protocol, ECIs included the following: 1) Events of potential drug-induced liver injury (DILI), defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, 2) Events associated with symptomatic hypotension, or 3) Events associated with anemia, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more ECIs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)	17.6 Percentage of participants	14.6 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

Potential DILI ECIs were determined and reported based on the clinical judgment of the investigator. Potential DILI ECIs were defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the ULN and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more potential DILI ECIs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Potential DILI ECIs	0.3 Percentage of Participants	0.4 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

Symptomatic hypotension ECIs were determined and reported based on the clinical judgment of the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more symptomatic hypotension ECIs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Symptomatic Hypotension ECIs	11.3 Percentage of Participants	9.2 Percentage of Participants

SECONDARY outcome

Timeframe: Up to approximately 36 months (from randomization to the primary completion data cutoff)

Population: All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.

Anemia ECIs were determined and reported based on the clinical judgment of the investigator, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more anemia ECIs is presented.

Outcome measures

Measure	Vericiguat n=3049 Participants Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 Participants Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Percentage of Participants Who Experienced One or More Anemia ECIs	7.6 Percentage of Participants	6.3 Percentage of Participants

Adverse Events

Vericiguat

Serious events: 732 serious events

Other events: 530 other events

Deaths: 392 deaths

Placebo

Serious events: 766 serious events

Other events: 423 other events

Deaths: 455 deaths

Serious adverse events

Measure	Vericiguat n=3049 participants at risk Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 participants at risk Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Blood and lymphatic system disorders Anaemia	0.85% 26/3049 • Number of events 28 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	1.1% 34/3049 • Number of events 35 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Anaemia macrocytic	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Aplastic anaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Coagulopathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Haemolytic anaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Hypercoagulation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Immune thrombocytopenia	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Iron deficiency anaemia	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Microcytic anaemia	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Neutropenia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Acute coronary syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Acute left ventricular failure	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Acute myocardial infarction	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.46% 14/3049 • Number of events 15 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Angina pectoris	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Angina unstable	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Aortic valve incompetence	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Aortic valve stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Arrhythmia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Arrhythmic storm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Atrial fibrillation	0.79% 24/3049 • Number of events 26 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.79% 24/3049 • Number of events 26 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Atrial flutter	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Atrial thrombosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Atrioventricular block complete	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Bradycardia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac arrest	0.13% 4/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac failure	4.0% 122/3049 • Number of events 134 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	3.8% 117/3049 • Number of events 136 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac failure acute	0.30% 9/3049 • Number of events 11 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.46% 14/3049 • Number of events 17 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac failure chronic	0.39% 12/3049 • Number of events 13 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac failure congestive	0.33% 10/3049 • Number of events 10 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.39% 12/3049 • Number of events 12 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac tamponade	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiac ventricular thrombosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiogenic shock	0.33% 10/3049 • Number of events 10 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.52% 16/3049 • Number of events 16 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiomyopathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Cardiorenal syndrome	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Chronic coronary syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Coronary artery disease	0.36% 11/3049 • Number of events 11 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.33% 10/3049 • Number of events 12 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Coronary artery occlusion	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Coronary artery stenosis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Dilated cardiomyopathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Extrasystoles	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Heart failure with reduced ejection fraction	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ischaemic cardiomyopathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Left ventricular failure	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Low cardiac output syndrome	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Mitral valve incompetence	0.30% 9/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Myocardial infarction	0.30% 9/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.26% 8/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Myocardial injury	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Myocardial ischaemia	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Nodal arrhythmia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Pulseless electrical activity	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Right ventricular failure	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Sinus node dysfunction	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Supraventricular tachycardia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Tachyarrhythmia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Tachycardia	0.07% 2/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Tricuspid valve incompetence	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ventricular arrhythmia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ventricular extrasystoles	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ventricular fibrillation	0.16% 5/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ventricular flutter	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Cardiac disorders Ventricular tachycardia	0.46% 14/3049 • Number of events 16 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.72% 22/3049 • Number of events 25 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Congenital, familial and genetic disorders Phimosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Congenital, familial and genetic disorders Reproductive tract hypoplasia, male	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Ear and labyrinth disorders Sudden hearing loss	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Ear and labyrinth disorders Vertigo	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Ear and labyrinth disorders Vertigo positional	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Endocrine disorders Hyperparathyroidism primary	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Endocrine disorders Hyperthyroidism	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Endocrine disorders Primary adrenal insufficiency	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Eye disorders Amaurosis fugax	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Eye disorders Cataract	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Eye disorders Cystoid macular oedema	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Eye disorders Retinal vein occlusion	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Abdominal hernia	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Abdominal pain	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Abdominal pain upper	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Abdominal wall haematoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Anal fistula	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Anal incontinence	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Ascites	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Colitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Constipation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Diarrhoea	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Diverticular perforation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Diverticulum	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Diverticulum intestinal	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Duodenitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Dyspepsia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Dysphagia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Enteritis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Erosive oesophagitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastric mucosa erythema	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastric polyps	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastritis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastritis erosive	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastritis haemorrhagic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.39% 12/3049 • Number of events 12 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gastrointestinal wall thickening	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Gingival bleeding	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Ileus	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Incarcerated inguinal hernia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Incarcerated umbilical hernia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Inguinal hernia	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Intestinal ischaemia	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Intestinal perforation	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Large intestine polyp	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Mallory-Weiss syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Mesenteric arteriosclerosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Mesenteric vein thrombosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Obstructive pancreatitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Oesophageal spasm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Oesophagitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Pancreatitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Pancreatitis acute	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Peptic ulcer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Proctitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Rectal haemorrhage	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Rectal polyp	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Reflux gastritis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Small intestinal obstruction	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Splenic artery aneurysm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.26% 8/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Gastrointestinal disorders Vomiting	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Asthenia	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Catheter site haematoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Chest discomfort	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Chest pain	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Complication associated with device	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Death	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Gait disturbance	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders General physical health deterioration	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Granuloma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Medical device site haematoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Multiple organ dysfunction syndrome	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Non-cardiac chest pain	0.23% 7/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Pyrexia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Strangulated hernia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Sudden cardiac death	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Sudden death	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Systemic inflammatory response syndrome	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Ulcer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
General disorders Vascular stent stenosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Bile duct stone	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholangitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholangitis acute	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholecystitis	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholecystitis acute	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholecystitis chronic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Cholelithiasis	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Drug-induced liver injury	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Hepatic cirrhosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Hepatic failure	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Hepatic function abnormal	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Hepatic haematoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Ischaemic hepatitis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Liver injury	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Hepatobiliary disorders Suspected drug-induced liver injury	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Immune system disorders Anaphylactic reaction	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Abscess limb	0.07% 2/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Acute endocarditis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Anal abscess	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Appendicitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Appendicitis perforated	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Arthritis bacterial	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Arthritis infective	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Bacteraemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Biliary sepsis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Bone tuberculosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Breast abscess	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Bronchitis	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Bronchitis bacterial	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations COVID-19	0.66% 20/3049 • Number of events 20 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.79% 24/3049 • Number of events 24 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations COVID-19 pneumonia	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Campylobacter gastroenteritis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Campylobacter infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Cellulitis	0.30% 9/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.49% 15/3049 • Number of events 16 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Chagas' cardiomyopathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Chronic sinusitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Clostridial infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Clostridium colitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Clostridium difficile colitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Clostridium difficile infection	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Complicated appendicitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Coronavirus pneumonia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Cystitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Dengue fever	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Device related infection	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Device related sepsis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Diabetic foot infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Diabetic gangrene	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Diverticulitis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Emphysematous cystitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Empyema	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Encephalitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Endocarditis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Endophthalmitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Endotoxaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Enterocolitis viral	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Epididymitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Erysipelas	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Escherichia bacteraemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Escherichia infection	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Escherichia sepsis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Escherichia urinary tract infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Fournier's gangrene	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Gangrene	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Gastroenteritis	0.36% 11/3049 • Number of events 11 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.26% 8/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Gastroenteritis viral	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations HIV infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Herpes zoster	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Implant site infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Infected skin ulcer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Infection	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Infectious pleural effusion	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Influenza	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Intervertebral discitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Intestinal sepsis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Klebsiella bacteraemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Localised infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Lower respiratory tract infection	0.26% 8/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Malaria	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Mastoiditis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Orchitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Osteomyelitis	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Osteomyelitis chronic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Parainfluenzae virus infection	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Perirectal abscess	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Peritonitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Peritonsillar abscess	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia	2.4% 73/3049 • Number of events 83 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	2.6% 78/3049 • Number of events 88 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia aspiration	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia bacterial	0.23% 7/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia haemophilus	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia influenzal	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia legionella	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia pneumococcal	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pneumonia viral	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Post procedural sepsis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pulmonary sepsis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pulmonary tuberculosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pyelonephritis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Pyelonephritis acute	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Respiratory syncytial virus infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Respiratory tract infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Respiratory tract infection viral	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Rhinovirus infection	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Sepsis	0.46% 14/3049 • Number of events 14 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.59% 18/3049 • Number of events 18 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Septic shock	0.39% 12/3049 • Number of events 12 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.62% 19/3049 • Number of events 19 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Skin infection	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Soft tissue infection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Staphylococcal sepsis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Subcutaneous abscess	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Tracheobronchitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Upper respiratory tract infection	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Urinary tract infection	0.62% 19/3049 • Number of events 19 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.56% 17/3049 • Number of events 18 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Urosepsis	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Vascular device infection	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Vestibular neuronitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Viral infection	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Wound infection	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Infections and infestations Wound infection staphylococcal	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Accident	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Acetabulum fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Ankle fracture	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Burns third degree	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Contusion	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Craniocerebral injury	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Craniofacial fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Fall	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Femur fracture	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.30% 9/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Hand fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Head injury	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Heat stroke	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Hip fracture	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.26% 8/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Humerus fracture	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Injury	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Intentional overdose	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Multiple fractures	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Overdose	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Patella fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Pelvic fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Periprosthetic fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Poisoning	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Radiation proctitis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Rib fracture	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Shoulder fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Skin injury	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Subdural haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Thermal burn	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Tibia fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Toxicity to various agents	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Ulna fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Injury, poisoning and procedural complications Vasoplegia syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Anticoagulation drug level above therapeutic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Blood creatinine increased	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Blood glucose increased	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Blood potassium increased	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Clostridium test positive	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Ejection fraction decreased	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations General physical condition abnormal	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations International normalised ratio increased	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Liver function test abnormal	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Investigations Myocardial necrosis marker increased	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Cachexia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Decreased appetite	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Dehydration	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Diabetes mellitus	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Electrolyte imbalance	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Gout	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hyperkalaemia	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.46% 14/3049 • Number of events 15 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypervolaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypokalaemia	0.10% 3/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypomagnesaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hyponatraemia	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Hypovolaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 3/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Bone cyst	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Bursitis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Pain in extremity	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.07% 2/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal neoplasm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix cancer metastatic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cutaneous T-cell lymphoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant fibrous histiocytoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant nipple neoplasm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome with single lineage dysplasia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm prostate	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Amnesia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Carotid artery disease	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Carotid artery stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Cerebral artery embolism	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Cerebral haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Cerebral infarction	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Cerebrovascular accident	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Cerebrovascular disorder	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Dementia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Diabetic neuropathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Dizziness	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Dyskinesia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Encephalopathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Epilepsy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Haemorrhagic stroke	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Headache	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Ischaemic stroke	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Lacunar infarction	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Loss of consciousness	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Metabolic encephalopathy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Miller Fisher syndrome	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Myelopathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Neuralgia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Neuromyelitis optica spectrum disorder	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Paralysis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Polyneuropathy	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Post herpetic neuralgia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Presyncope	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Reversible ischaemic neurological deficit	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Sciatica	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Seizure	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Spinal cord ischaemia	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Subarachnoid haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Syncope	0.59% 18/3049 • Number of events 19 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.43% 13/3049 • Number of events 13 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Nervous system disorders Transient ischaemic attack	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Product Issues Device dislocation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Product Issues Device malfunction	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Product Issues Device power source issue	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Product Issues Lead dislodgement	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Alcohol abuse	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Confusional state	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Delirium	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Depression	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Mental status changes	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Psychiatric disorders Suicide attempt	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Acute kidney injury	1.0% 32/3049 • Number of events 32 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	1.8% 56/3049 • Number of events 62 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Bladder diverticulum	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Bladder mass	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Bladder stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Bladder tamponade	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Chronic kidney disease	0.49% 15/3049 • Number of events 17 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.52% 16/3049 • Number of events 18 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders End stage renal disease	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Haematuria	0.10% 3/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Hydronephrosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Nephrolithiasis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Nephropathy	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Nephropathy toxic	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Oliguria	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Renal colic	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Renal failure	0.56% 17/3049 • Number of events 18 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Renal haematoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Renal impairment	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Renal infarct	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Ureterolithiasis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Urethral fistula	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Urethral meatus stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Urethral stenosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Renal and urinary disorders Urinary retention	0.16% 5/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Reproductive system and breast disorders Uterovaginal prolapse	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.26% 8/3049 • Number of events 9 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Cheyne-Stokes respiration	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.43% 13/3049 • Number of events 27 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.43% 13/3049 • Number of events 17 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 8/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Hiccups	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Idiopathic interstitial pneumonia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 4/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.13% 4/3049 • Number of events 4 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.07% 2/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.26% 8/3049 • Number of events 8 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Angioedema	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Diabetic foot	0.23% 7/3049 • Number of events 7 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Skin disorder	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Skin hypertrophy	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.16% 5/3049 • Number of events 5 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Skin ulcer haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Surgical and medical procedures Hospitalisation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Aortic aneurysm	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Aortic aneurysm rupture	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Aortic dilatation	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Aortic dissection	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Aortic stenosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Arteriosclerosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Deep vein thrombosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Distributive shock	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Embolism venous	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Extremity necrosis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Giant cell arteritis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Haematoma	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Haemorrhage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypertension	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypertensive crisis	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypertensive emergency	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypertensive end-organ damage	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypotension	0.98% 30/3049 • Number of events 32 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.95% 29/3049 • Number of events 29 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypovolaemic shock	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Ischaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Orthostatic hypotension	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Peripheral arterial occlusive disease	0.20% 6/3049 • Number of events 6 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.39% 12/3049 • Number of events 12 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Peripheral artery occlusion	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Peripheral ischaemia	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.10% 3/3049 • Number of events 3 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Peripheral vascular disorder	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Peripheral vascular haematoma	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Scalp haematoma	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Shock	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Shock haemorrhagic	0.07% 2/3049 • Number of events 2 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Thrombophlebitis	0.00% 0/3049 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	0.03% 1/3049 • Number of events 1 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.

Other adverse events

Measure	Vericiguat n=3049 participants at risk Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).	Placebo n=3049 participants at risk Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).
Blood and lymphatic system disorders Anaemia	5.6% 171/3049 • Number of events 190 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	4.7% 143/3049 • Number of events 154 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.
Vascular disorders Hypotension	13.2% 401/3049 • Number of events 502 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.	10.2% 312/3049 • Number of events 380 • Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff) One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
• Publication restrictions are in place

Restriction type: OTHER