Trial Outcomes & Findings for Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (NCT NCT03473223)

NCT ID: NCT03473223

Last Updated: 2025-01-14

Results Overview

MACE (Major adverse cardiovascular event\[s\])(CV \[cardiovascular\] death, MI \[Myocardial Infarction\], or stroke).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 18226 participants
• Primary outcome timeframe: From the time of randomization through 90 days
• Results posted on: 2025-01-14

Participant Flow

The study was conducted at 897 centers across 5 regions (North America, Latin America, Western Europe, Central and Eastern Europe, and Asia Pacific).

A total of 18,848 participants were screened, with 622 identified as screen failures. Of the screened participants, 18,226 were randomized in a 1:1 ratio to receive study interventions (CSL112 or Placebo).

Participant milestones

Measure	CSL112 Participants received 6 grams of CSL112 (Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma) once weekly via intravenous (IV) infusion for up to 4 weeks.	Placebo Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Overall Study STARTED	9114	9112
Overall Study Intent-to-treat (ITT) Analysis Set	9112	9107
Overall Study Safety Analysis Set (SAS)	9010	9027
Overall Study COMPLETED	9002	9020
Overall Study NOT COMPLETED	112	92

Reasons for withdrawal

Measure	CSL112 Participants received 6 grams of CSL112 (Apolipoprotein A-I \[human\] (apoA-I) purified from human plasma) once weekly via intravenous (IV) infusion for up to 4 weeks.	Placebo Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	47	42
Overall Study Indirect contact	32	29
Overall Study Other (Not specified)	32	20

Baseline Characteristics

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

Baseline characteristics by cohort

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.	Total n=18219 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 10.09 • n=5 Participants	65.4 years STANDARD_DEVIATION 10.21 • n=7 Participants	65.5 years STANDARD_DEVIATION 10.15 • n=5 Participants
Sex: Female, Male Female	2326 Participants n=5 Participants	2386 Participants n=7 Participants	4712 Participants n=5 Participants
Sex: Female, Male Male	6786 Participants n=5 Participants	6721 Participants n=7 Participants	13507 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1566 Participants n=5 Participants	1596 Participants n=7 Participants	3162 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7410 Participants n=5 Participants	7383 Participants n=7 Participants	14793 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	136 Participants n=5 Participants	128 Participants n=7 Participants	264 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	51 Participants n=5 Participants	36 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) Asian	743 Participants n=5 Participants	781 Participants n=7 Participants	1524 Participants n=5 Participants
Race (NIH/OMB) Black or African American	181 Participants n=5 Participants	181 Participants n=7 Participants	362 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or other Pacific Islander	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	7769 Participants n=5 Participants	7698 Participants n=7 Participants	15467 Participants n=5 Participants
Race (NIH/OMB) Multiracial or other	314 Participants n=5 Participants	356 Participants n=7 Participants	670 Participants n=5 Participants
Race (NIH/OMB) Not Reported by subject	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of randomization through 90 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

MACE (Major adverse cardiovascular event[s])(CV [cardiovascular] death, MI [Myocardial Infarction], or stroke).

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)	439 Participants	472 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 90 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

The total number of hospitalizations and individual hospitalizations due to coronary, cerebral, and peripheral ischemia were reported.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia Total hospitalizations	433 hospitalizations	442 hospitalizations
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia Coronary ischemia	367 hospitalizations	376 hospitalizations
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia Cerebral ischemia	39 hospitalizations	36 hospitalizations
Total Number of Hospitalizations for Coronary, Cerebral, and Peripheral Ischemia Peripheral ischemia	27 hospitalizations	30 hospitalizations

SECONDARY outcome

Timeframe: From the time of randomization through 180 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of CV Death, MI, or Stroke	622 Participants	683 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 365 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of CV Death, MI, or Stroke	885 Participants	944 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 90 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With Occurrence of CV Death	107 Participants	128 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 90 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of MI	312 Participants	342 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 90 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of Stroke	57 Participants	49 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 90, 180 and 365 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke Through Day 90	272 Participants	308 Participants
Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke Through Day 180	400 Participants	444 Participants
Number of Participants With First Occurrence of CV Death, Type 1 MI or Stroke Through Day 365	594 Participants	639 Participants

SECONDARY outcome

Timeframe: From the time of randomization through 365 days

Population: Analysis was performed on the ITT analysis set. The ITT analysis set comprised all randomized participants with the exception of 7 participants enrolled at site(s) excluded from analysis per sponsor decision. The ITT analysis set utilized the treatment to which the participant was randomized regardless of the treatment actually received.

Outcome measures

Measure	CSL112 n=9112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9107 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With Occurrence of All-cause Death	341 Participants	345 Participants

SECONDARY outcome

Timeframe: From the start of treatment through 90 days

Population: Analysis was performed on the Safety analysis set (SAS). The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With Adverse Events	3938 Participants	3927 Participants

SECONDARY outcome

Timeframe: From the start of treatment through 90 days

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

An AE was defined as any unfavorable and unintended sign (including an abnormal, clinically significant laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Percentage of Participants With Adverse Events	43.7 percentage of participants	43.5 percentage of participants

SECONDARY outcome

Timeframe: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With Treatment-related Adverse Events	350 Participants	304 Participants

SECONDARY outcome

Timeframe: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

Treatment-related AEs were AEs considered by the Investigator to have a causal relationship to the investigational product. As per the study statistical analysis plan (SAP), descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Percentage of Participants With Treatment-related Adverse Events	3.9 percentage of participants	3.4 percentage of participants

SECONDARY outcome

Timeframe: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is a medically significant event.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With Serious Adverse Events (SAEs)	1514 Participants	1557 Participants

SECONDARY outcome

Timeframe: From the start of treatment through 379 days (Day 365 + 14 days of follow up)

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received.

SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect or is a medically significant event. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

Outcome measures

Measure	CSL112 n=9010 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Percentage of Participants With SAEs	16.8 percentage of participants	17.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 29 days

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified category.

Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin, direct bilirubin, indirect bilirubin and estimated glomerular filtration rate [eGFR]). The number of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment.

Outcome measures

Measure	CSL112 n=8372 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8392 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hematocrit - High to Low	0 Participants	1 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hematocrit - Normal to Low	365 Participants	393 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hemoglobin - High to Low	0 Participants	1 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hemoglobin - Normal to Low	457 Participants	447 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Leukocytes - Normal to High	267 Participants	271 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Leukocytes - Low to High	2 Participants	1 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Platelets - High to Low	0 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Platelets - Normal to Low	92 Participants	114 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALT - Normal to High	658 Participants	612 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALT - Low to High	0 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALP - Normal to High	307 Participants	350 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALP - Low to High	1 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments AST - Normal to High	239 Participants	253 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments AST - Low to High	2 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Bilirubin - Low to High	0 Participants	1 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Direct Bilirubin - Normal to High	18 Participants	21 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Direct Bilirubin - Low to High	0 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Indirect Bilirubin - Normal to High	31 Participants	42 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Indirect Bilirubin - Low to High	0 Participants	0 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Normal to Severe Impairment	1 Participants	2 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Mild Impairment to Severe Impairment	15 Participants	9 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Bilirubin - Normal to High	73 Participants	112 Participants
Number of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Moderate Impairment to Severe Impairment	91 Participants	99 Participants

SECONDARY outcome

Timeframe: Baseline and 29 days

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified category.

Clinical laboratory assessments included assessment of Hematology (hemoglobin, hematocrit, leukocytes and platelets) and Biochemistry (ALP, ALT, AST, bilirubin, direct bilirubin, indirect bilirubin and eGFR). Percentage of participants with a shift from the Baseline value to the worst post-treatment value (low, normal, or high) was reported. The worst criterion for the parameters is as follows: hematocrit - low, hemoglobin - low, leukocytes - high, platelets - low, ALT - high, ALP - high, AST - high, bilirubin - high, direct bilirubin - high, indirect bilirubin - high, eGFR - severe impairment. As per the study SAP, descriptive percentages were displayed to one decimal place, hence the percentage values were rounded off and presented.

Outcome measures

Measure	CSL112 n=8372 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8392 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hemoglobin - Normal to Low	6.3 percentage of participants	6.2 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hematocrit - High to Low	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hematocrit - Normal to Low	5.3 percentage of participants	5.8 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Hemoglobin - High to Low	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Leukocytes - Normal to High	3.7 percentage of participants	3.8 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Leukocytes - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Platelets - High to Low	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Platelets - Normal to Low	1.3 percentage of participants	1.6 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALT - Normal to High	8.3 percentage of participants	7.7 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALT - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALP - Normal to High	3.7 percentage of participants	4.2 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments ALP - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments AST - Normal to High	3.0 percentage of participants	3.2 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments AST - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Bilirubin - Normal to High	0.9 percentage of participants	1.4 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Bilirubin - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Direct Bilirubin - Normal to High	0.2 percentage of participants	0.3 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Direct Bilirubin - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Indirect Bilirubin - Normal to High	0.4 percentage of participants	0.6 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments Indirect Bilirubin - Low to High	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Normal to Severe Impairment	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Mild Impairment to Severe Impairment	0.2 percentage of participants	0.1 percentage of participants
Percentage of Participants With a Shift From Baseline to Worst Post-treatment Value in Clinical Laboratory Assessments eGFR - Moderate Impairment to Severe Impairment	1.1 percentage of participants	1.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified category.

Hematology parameters included Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets.

Outcome measures

Measure	CSL112 n=7073 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=7021 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Hematology Parameters Leukocytes	-1.024 10^9 cells per liter Standard Deviation 2.2905	-0.969 10^9 cells per liter Standard Deviation 2.2683
Change From Baseline in Hematology Parameters Lymphocytes	0.084 10^9 cells per liter Standard Deviation 0.5534	0.080 10^9 cells per liter Standard Deviation 0.5409
Change From Baseline in Hematology Parameters Monocytes	-0.089 10^9 cells per liter Standard Deviation 0.1886	-0.087 10^9 cells per liter Standard Deviation 0.1961
Change From Baseline in Hematology Parameters Basophils	0.004 10^9 cells per liter Standard Deviation 0.0455	0.005 10^9 cells per liter Standard Deviation 0.0462
Change From Baseline in Hematology Parameters Eosinophils	0.045 10^9 cells per liter Standard Deviation 0.1766	0.047 10^9 cells per liter Standard Deviation 0.1727
Change From Baseline in Hematology Parameters Neutrophils	-1.068 10^9 cells per liter Standard Deviation 2.0892	-1.011 10^9 cells per liter Standard Deviation 2.0343
Change From Baseline in Hematology Parameters Platelets	0.4 10^9 cells per liter Standard Deviation 56.09	-1.4 10^9 cells per liter Standard Deviation 55.31

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure.

Outcome measures

Measure	CSL112 n=6698 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=6651 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Hematology Parameter: Hematocrit	-0.003 liter per liter (L/L) Standard Deviation 0.0382	-0.004 liter per liter (L/L) Standard Deviation 0.0381

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure.

Outcome measures

Measure	CSL112 n=7074 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=7021 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Hematology Parameter: Hemoglobin	-1.1 grams per liter (g/L) Standard Deviation 11.96	-1.3 grams per liter (g/L) Standard Deviation 12.08

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for each specified category.

Hepatic parameters included ALT, ALP and AST.

Outcome measures

Measure	CSL112 n=8079 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8072 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Hepatic Parameters ALT	-5.5 units per liter Standard Deviation 25.52	-6.5 units per liter Standard Deviation 28.91
Change From Baseline in Hepatic Parameters ALP	3.2 units per liter Standard Deviation 26.13	4.5 units per liter Standard Deviation 24.55
Change From Baseline in Hepatic Parameters AST	-21.2 units per liter Standard Deviation 41.90	-20.7 units per liter Standard Deviation 61.63

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for each specified category.

Outcome measures

Measure	CSL112 n=8005 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=7983 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Hepatic Parameter: Bilirubin Bilirubin	-2.6 micromol per liter (umol/L) Standard Deviation 4.71	-1.9 micromol per liter (umol/L) Standard Deviation 5.05
Change From Baseline in Hepatic Parameter: Bilirubin Direct Bilirubin	-0.4 micromol per liter (umol/L) Standard Deviation 1.32	-0.3 micromol per liter (umol/L) Standard Deviation 1.75
Change From Baseline in Hepatic Parameter: Bilirubin Indirect Bilirubin	-2.0 micromol per liter (umol/L) Standard Deviation 3.85	-1.4 micromol per liter (umol/L) Standard Deviation 3.90

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure.

Outcome measures

Measure	CSL112 n=8114 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8101 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Renal Parameter: Serum Creatinine	2.4 umol/L Standard Deviation 24.39	2.1 umol/L Standard Deviation 21.23

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure.

Outcome measures

Measure	CSL112 n=8112 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8098 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Renal Parameter: eGFR	-1.3 milliliter per minute per 1.73 meter^2 Standard Deviation 11.87	-1.2 milliliter per minute per 1.73 meter^2 Standard Deviation 12.15

SECONDARY outcome

Timeframe: From Baseline to Day 29

Population: Analysis was performed on the SAS. The SAS comprised all participants in the ITT Analysis set who received any amount of the investigational product, and were analyzed based on the actual treatment received. Here, the Overall Number of Participants Analyzed (N), included all participants who were evaluated for this outcome measure.

Outcome measures

Measure	CSL112 n=8114 Participants Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=8105 Participants Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Change From Baseline in Renal Parameter: Blood Urea Nitrogen	0.0 millimoles per liter Standard Deviation 2.76	0.0 millimoles per liter Standard Deviation 2.67

Adverse Events

CSL112

Serious events: 1514 serious events

Other events: 0 other events

Deaths: 348 deaths

Placebo

Serious events: 1557 serious events

Other events: 0 other events

Deaths: 355 deaths

Serious adverse events

Measure	CSL112 n=9010 participants at risk Participants received 6 grams of CSL112 (apoA-I purified from human plasma) once weekly via IV infusion for up to 4 weeks.	Placebo n=9027 participants at risk Participants received placebo (25% albumin solution diluted to 4.4%) once weekly via IV infusion for up to 4 weeks.
Cardiac disorders Angina pectoris	1.2% 106/9010 • Number of events 107 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.93% 84/9027 • Number of events 89 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Angina unstable	0.77% 69/9010 • Number of events 73 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.65% 59/9027 • Number of events 63 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac failure	0.60% 54/9010 • Number of events 61 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.71% 64/9027 • Number of events 67 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrial fibrillation	0.53% 48/9010 • Number of events 50 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.53% 48/9027 • Number of events 53 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery disease	0.26% 23/9010 • Number of events 23 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.30% 27/9027 • Number of events 28 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ventricular tachycardia	0.22% 20/9010 • Number of events 21 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.23% 21/9027 • Number of events 24 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Acute myocardial infarction	0.21% 19/9010 • Number of events 19 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.32% 29/9027 • Number of events 29 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Myocardial infarction	0.16% 14/9010 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.18% 16/9027 • Number of events 16 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Myocardial ischaemia	0.16% 14/9010 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.21% 19/9027 • Number of events 19 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac failure congestive	0.16% 14/9010 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.25% 23/9027 • Number of events 24 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrial flutter	0.13% 12/9010 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.17% 15/9027 • Number of events 16 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac arrest	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.14% 13/9027 • Number of events 13 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Pericarditis	0.11% 10/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiogenic shock	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery stenosis	0.10% 9/9010 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Acute coronary syndrome	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrioventricular block complete	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.11% 10/9027 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Sinus node dysfunction	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac failure acute	0.08% 7/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Left ventricular failure	0.08% 7/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Supraventricular tachycardia	0.08% 7/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Bradycardia	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrioventricular block second degree	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ischaemic cardiomyopathy	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Mitral valve incompetence	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ventricular fibrillation	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Torsade de pointes	0.04% 4/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrioventricular block	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery occlusion	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Dressler's syndrome	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Pericardial effusion	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Postinfarction angina	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ventricular extrasystoles	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardio-respiratory arrest	0.03% 3/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac failure chronic	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery perforation	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Acute left ventricular failure	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Aortic valve stenosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Arrhythmia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac tamponade	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac ventricular thrombosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Mitral valve stenosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Myocardial injury	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Palpitations	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Sinus arrest	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Aortic valve incompetence	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Arrhythmia supraventricular	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Arteriospasm coronary	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrial tachycardia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Atrioventricular block first degree	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac asthma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac discomfort	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiomyopathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Chronic coronary syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery dissection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Coronary artery insufficiency	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Left ventricular dysfunction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Low cardiac output syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Mitral valve disease	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Myocardial rupture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Nodal rhythm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Pericardial haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Prinzmetal angina	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Pulseless electrical activity	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Right ventricular failure	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Sinus bradycardia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Sinus tachycardia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Tachyarrhythmia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ventricular arrhythmia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Anginal equivalent	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiac dysfunction	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiorenal syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Cardiovascular insufficiency	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Extrasystoles	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Intracardiac thrombus	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Myocarditis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Pericardial mass	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Stress cardiomyopathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Trifascicular block	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Cardiac disorders Ventricle rupture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia	1.1% 97/9010 • Number of events 99 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.99% 89/9027 • Number of events 93 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations COVID-19 pneumonia	0.58% 52/9010 • Number of events 52 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.51% 46/9027 • Number of events 47 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations COVID-19	0.47% 42/9010 • Number of events 42 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.53% 48/9027 • Number of events 49 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Urinary tract infection	0.41% 37/9010 • Number of events 38 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.40% 36/9027 • Number of events 39 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Sepsis	0.29% 26/9010 • Number of events 26 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.29% 26/9027 • Number of events 26 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Urosepsis	0.13% 12/9010 • Number of events 13 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gastroenteritis	0.13% 12/9010 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Cellulitis	0.10% 9/9010 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.19% 17/9027 • Number of events 19 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bronchitis	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Respiratory tract infection	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Septic shock	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.25% 23/9027 • Number of events 23 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Osteomyelitis	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Influenza	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Peritonitis	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Postoperative wound infection	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyelonephritis	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Upper respiratory tract infection	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Appendicitis	0.04% 4/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia bacterial	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Diverticulitis	0.03% 3/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bacteraemia	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Endocarditis	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Staphylococcal bacteraemia	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gastrointestinal infection	0.02% 2/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia aspiration	0.02% 2/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Abscess limb	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Cholecystitis infective	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Clostridium difficile colitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Epididymitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Erysipelas	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gastroenteritis viral	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Infection	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Intervertebral discitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Localised infection	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Ophthalmic herpes zoster	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Parapharyngeal space infection	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia klebsiella	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Urinary tract infection bacterial	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Viral infection	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Lung abscess	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pulmonary sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Acarodermatitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Anal abscess	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Aortitis syphilitic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Appendicitis perforated	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Arthritis bacterial	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Arthritis infective	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Babesiosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bacterial sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Biliary sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bronchiolitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bursitis infective	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Campylobacter gastroenteritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Chikungunya virus infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Complicated appendicitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Coronavirus pneumonia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Cystitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Dengue fever	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Device related sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Diabetic foot infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Diverticulitis intestinal haemorrhagic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Emphysematous cystitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Enterococcal bacteraemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Enterococcal sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Escherichia bacteraemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Escherichia pyelonephritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Escherichia urinary tract infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gangrene	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gastroenteritis bacterial	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Groin infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Helicobacter infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Hepatitis E	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Herpes zoster	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Infected skin ulcer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Klebsiella sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Klebsiella urinary tract infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Mediastinitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Medical device site infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Medical device site joint infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Muscle abscess	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Nasopharyngitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Osteomyelitis acute	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pelvic abscess	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia pneumococcal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia pseudomonal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia staphylococcal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia viral	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pulmonary tuberculosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyelonephritis acute	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyelonephritis chronic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Rectal abscess	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Respiratory tract infection bacterial	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Salmonella sepsis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Sinusitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Sternitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Thrombophlebitis septic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Tooth abscess	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Tracheobronchitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Urinary tract infection enterococcal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Vascular access site infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Vestibular neuronitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Viral upper respiratory tract infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Wound infection	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Abscess neck	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Atypical pneumonia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Bacterial prostatitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Chronic sinusitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Citrobacter sepsis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Clostridium difficile infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Cystitis klebsiella	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Cytomegalovirus colitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Device related infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Diarrhoea infectious	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Endocarditis enterococcal	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Enterobacter pneumonia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Erysipelothrix sepsis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Escherichia sepsis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Furuncle	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gas gangrene	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Gastroenteritis salmonella	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Giardiasis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Groin abscess	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Helicobacter gastritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Hepatitis B	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Herpes zoster disseminated	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Kidney infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Klebsiella bacteraemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Large intestine infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Lower respiratory tract infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Necrotising fasciitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Orchitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Otitis externa	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Peritoneal abscess	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia acinetobacter	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pneumonia legionella	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Post procedural infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Post-acute COVID-19 syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyoderma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyonephrosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Pyuria	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Retroperitoneal abscess	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Skin infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Staphylococcal infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Strongyloidiasis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Subcutaneous abscess	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Tuberculosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Infections and infestations Vascular device infection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.14% 13/9010 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.21% 19/9027 • Number of events 19 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastritis	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Abdominal pain	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.08% 7/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Rectal haemorrhage	0.07% 6/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastric ulcer haemorrhage	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatitis acute	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Dyspepsia	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Melaena	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Colitis ischaemic	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diarrhoea	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intestinal obstruction	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatitis	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Duodenal ulcer	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal polyp haemorrhage	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Haematemesis	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Ileus	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intestinal haemorrhage	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Dysphagia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastric haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastric ulcer	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastritis erosive	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastritis haemorrhagic	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gingival bleeding	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Haematochezia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Inguinal hernia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestinal stenosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestine polyp	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Mallory-Weiss syndrome	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Obstructive pancreatitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Vomiting	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Abdominal discomfort	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Abdominal hernia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Abdominal pain upper	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Aphthous ulcer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Ascites	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Colitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Constipation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Crohn's disease	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Dental caries	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diverticulum	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Enterocolitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastric antral vascular ectasia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal pain	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal polyp	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal vascular malformation haemorrhagic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Heyde's syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Ileus paralytic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Impaired gastric emptying	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Incarcerated inguinal hernia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intestinal pseudo-obstruction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Irritable bowel syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestinal haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestinal ulcer haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestine perforation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Mouth haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Nausea	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Oesophagitis haemorrhagic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatitis necrotising	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Peptic ulcer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Portal hypertensive gastropathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Proctitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Retroperitoneal haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Umbilical hernia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Acute abdomen	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Anal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Duodenitis haemorrhagic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Enteritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Food poisoning	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastric polyps	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal erosion	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Haemorrhoids	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intestinal perforation	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Mechanical ileus	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Noninfective sialoadenitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Oesophagitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatic atrophy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Reflux gastritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Acute kidney injury	0.75% 68/9010 • Number of events 72 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.73% 66/9027 • Number of events 71 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal impairment	0.17% 15/9010 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.16% 14/9027 • Number of events 17 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Haematuria	0.16% 14/9010 • Number of events 16 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.11% 10/9027 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal failure	0.13% 12/9010 • Number of events 13 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.16% 14/9027 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Nephropathy toxic	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Urinary retention	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Nephrolithiasis	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Chronic kidney disease	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Ureterolithiasis	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Calculus urinary	0.03% 3/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal colic	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal injury	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Bladder disorder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Calculus bladder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders End stage renal disease	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Nephropathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Pyelocaliectasis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal cyst	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal tubular necrosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Tubulointerstitial nephritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Urethral haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Urinary tract obstruction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Azotaemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Bladder diverticulum	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Bladder tamponade	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Calculus urethral	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Cystitis erosive	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Dysuria	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Hydronephrosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Neurogenic bladder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal infarct	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Renal salt-wasting syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Renal and urinary disorders Vesical fistula	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Non-cardiac chest pain	1.0% 92/9010 • Number of events 97 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.86% 78/9027 • Number of events 99 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Pyrexia	0.13% 12/9010 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Chest pain	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.17% 15/9027 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Vascular stent stenosis	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders General physical health deterioration	0.06% 5/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Gait disturbance	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Multiple organ dysfunction syndrome	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Medical device site haematoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Death	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Drowning	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Impaired healing	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Infusion site reaction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Oedema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Oedema peripheral	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Vascular stent occlusion	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Adverse drug reaction	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Asthenia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.11% 10/9027 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Chest discomfort	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Drug intolerance	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Fatigue	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Hernia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Immune-mediated polyserositis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Malaise	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Medical device site haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Peripheral swelling	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Physical deconditioning	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Sudden cardiac death	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Sudden death	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
General disorders Vascular stent thrombosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.23% 21/9010 • Number of events 28 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.32% 29/9027 • Number of events 41 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.19% 17/9010 • Number of events 17 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.14% 13/9027 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.16% 14/9010 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.09% 8/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.12% 11/9027 • Number of events 13 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Asthma	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Aspiration	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Cough	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Diaphragmatic abnormal relaxation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Emphysema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Hiccups	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Rales	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Tracheal fistula	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Alveolar proteinosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Mediastinal haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.03% 3/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage 0	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal adenocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage IV	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant oligodendroglioma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone marrow	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic uterine cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma recurrent	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of nipple	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urethral cancer metastatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Basal cell carcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage II	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline mucinous tumour of ovary	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm benign	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ciliary body melanoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer recurrent	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal papilloma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant urinary tract neoplasm	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma stage IV	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage II	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell cancer of renal pelvis and ureter metastatic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma recurrent	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Fall	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.12% 11/9027 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Subdural haematoma	0.10% 9/9010 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Femur fracture	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.12% 11/9027 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Head injury	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Hip fracture	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Periprocedural myocardial infarction	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Rib fracture	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Contusion	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Femoral neck fracture	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vascular access site haematoma	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Cardiac procedure complication	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Craniofacial fracture	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Humerus fracture	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Multiple injuries	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Pelvic fracture	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Procedural pneumothorax	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Spinal compression fracture	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Wound dehiscence	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Pancreatic leak	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Abdominal injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Anaemia postoperative	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Anal injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Back injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Chemical burns of eye	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Costal cartilage fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Eschar	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Exposure to SARS-CoV-2	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Extradural haematoma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Face injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Foot fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Hand fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Limb injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Overdose	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Postoperative thrombosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Procedural haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Renal transplant failure	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Skin laceration	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Spinal fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Sternal fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Tooth fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Traumatic renal injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Ulna fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Urinary retention postoperative	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vascular injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vulvovaginal injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Concussion	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Gas poisoning	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Gastrointestinal anastomotic haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Hyphaema	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Intervertebral disc injury	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural complication circulatory	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Procedural dizziness	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Radiation proctitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Respiratory tract procedural complication	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Scrotal haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Tracheal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Traumatic arthritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Vascular access site dissection	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypotension	0.19% 17/9010 • Number of events 19 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.17% 15/9027 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Aortic aneurysm	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypertension	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.16% 14/9027 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypertensive crisis	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 15 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Deep vein thrombosis	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral arterial occlusive disease	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.12% 11/9027 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Aortic stenosis	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Orthostatic hypotension	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.08% 7/9027 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral ischaemia	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Haematoma	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Aortic dissection	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypertensive emergency	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Phlebitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Thrombophlebitis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Angiodysplasia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Aortic thrombosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Arteriosclerosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Circulatory collapse	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Dialysis hypotension	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Extremity necrosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Granulomatosis with polyangiitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Haemodynamic instability	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypertensive urgency	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Hypovolaemic shock	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Iliac artery stenosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Lymphoedema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral artery stenosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Shock haemorrhagic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Accelerated hypertension	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Arterial occlusive disease	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Arterial rupture	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Arteriovenous fistula	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Diabetic vascular disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Dry gangrene	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Intermittent claudication	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Leriche syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral artery aneurysm	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral artery occlusion	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral artery thrombosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Peripheral vascular disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Raynaud's phenomenon	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Shock	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Vascular disorders Vasculitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Syncope	0.26% 23/9010 • Number of events 24 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.29% 26/9027 • Number of events 26 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Transient ischaemic attack	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.11% 10/9027 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Carotid artery stenosis	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Dizziness	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Loss of consciousness	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Seizure	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Presyncope	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.11% 10/9027 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebrovascular accident	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Epilepsy	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Metabolic encephalopathy	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Encephalopathy	0.02% 2/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebrovascular disorder	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Diabetic neuropathy	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Hypoaesthesia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Ischaemic stroke	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Subarachnoid haemorrhage	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Neuralgia	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Normal pressure hydrocephalus	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Parkinsonism	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Amnesia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Aphasia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Basal ganglia haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Brain oedema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Carotid sinus syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral artery stenosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral haemorrhage	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral ischaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebrovascular insufficiency	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Dementia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Diabetic coma	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Dizziness postural	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Dysarthria	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Generalised tonic-clonic seizure	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemorrhage intracranial	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Haemorrhagic stroke	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Haemorrhagic transformation stroke	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Hypoglycaemic encephalopathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Migraine	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Monoparesis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Post stroke epilepsy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Pseudoradicular syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Radiculopathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Status epilepticus	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Tension headache	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders VIth nerve paralysis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Brain injury	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Carotid artery aneurysm	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cauda equina syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral atrophy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Cerebral thrombosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Dystonia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Hemiparesis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Lethargy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Lumbar radiculopathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Parkinson's disease	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Partial seizures	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Polyneuropathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Restless legs syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Sciatica	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Somnolence	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Vertebral artery stenosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypoglycaemia	0.13% 12/9010 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hyperglycaemia	0.11% 10/9010 • Number of events 10 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.16% 14/9027 • Number of events 14 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Dehydration	0.10% 9/9010 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hyponatraemia	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hyperkalaemia	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.10% 9/9027 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Gout	0.03% 3/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Diabetes mellitus	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Failure to thrive	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Abnormal loss of weight	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Cachexia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Euglycaemic diabetic ketoacidosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypervolaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypokalaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypomagnesaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Ketoacidosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Lactic acidosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Metabolic acidosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Malnutrition	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Anaemia	0.44% 40/9010 • Number of events 45 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.43% 39/9027 • Number of events 43 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Iron deficiency anaemia	0.10% 9/9010 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.09% 8/9027 • Number of events 9 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Blood loss anaemia	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Thrombocytopenia	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Febrile neutropenia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Leukocytosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Lymph node pain	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Neutropenia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Normocytic anaemia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Pancytopenia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Acquired haemophilia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Microcytic anaemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Blood and lymphatic system disorders Splenic infarction	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholecystitis	0.63% 57/9010 • Number of events 64 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 13 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholecystitis acute	0.12% 11/9010 • Number of events 11 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.19% 17/9027 • Number of events 18 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Liver injury	0.08% 7/9010 • Number of events 7 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.13% 12/9027 • Number of events 12 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholelithiasis	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Bile duct stone	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholecystitis chronic	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Gallbladder rupture	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatic steatosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatitis acute	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Autoimmune hepatitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Biliary dyskinesia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Biliary obstruction	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholangitis acute	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholelithiasis obstructive	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Drug-induced liver injury	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatic cirrhosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatic fibrosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatitis cholestatic	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Biliary colic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Cholangitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatic failure	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.17% 15/9027 • Number of events 16 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Back pain	0.07% 6/9010 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Pain in extremity	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Arthralgia	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Costochondritis	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Arthritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Compartment syndrome	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Gouty arthritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Haematoma muscle	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Neck pain	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Pathological fracture	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Musculoskeletal and connective tissue disorders Spinal synovial cyst	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Troponin increased	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Hepatic enzyme increased	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Liver function test abnormal	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Alanine aminotransferase increased	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Ejection fraction decreased	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Haemoglobin decreased	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Influenza A virus test positive	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Anticoagulation drug level abnormal	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Bacterial test positive	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood creatinine increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood magnesium decreased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood potassium increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood pressure increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations C-reactive protein increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Glomerular filtration rate decreased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Inflammatory marker increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Liver function test increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Occult blood positive	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations SARS-CoV-2 test positive	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Troponin I increased	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Angiogram peripheral abnormal	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood bilirubin increased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood potassium decreased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Blood urine present	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Electrocardiogram QT prolonged	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Gram stain positive	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations International normalised ratio increased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Pulmonary arterial pressure increased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Staphylococcus test positive	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Troponin T increased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Investigations Weight decreased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Diabetic foot	0.09% 8/9010 • Number of events 8 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.06% 5/9027 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Rash	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Angioedema	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Dermal cyst	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Necrotic angiodermatitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Panniculitis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Psoriasis	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Diabetic wound	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Delirium	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Anxiety	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.07% 6/9027 • Number of events 6 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Panic attack	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Alcoholism	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Bipolar disorder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Confusional state	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Stress	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Suicidal ideation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Tobacco withdrawal symptoms	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Anxiety disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Anxiety disorder due to a general medical condition	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Completed suicide	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Depression	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Disorientation	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Mental status changes	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Psychiatric disorders Mixed anxiety and depressive disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Immune system disorders Hypersensitivity	0.06% 5/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Immune system disorders Anaphylactic reaction	0.04% 4/9010 • Number of events 5 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Immune system disorders Drug hypersensitivity	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Immune system disorders Cytokine storm	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Immune system disorders Anaphylactic shock	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Vertigo positional	0.04% 4/9010 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Deafness neurosensory	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Sudden hearing loss	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Vestibular disorder	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Deafness	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Deafness unilateral	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Ear and labyrinth disorders Vertigo	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Cataract	0.02% 2/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Cataract nuclear	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Eye allergy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Optic ischaemic neuropathy	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Retinopathy hypertensive	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Vision blurred	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Blindness unilateral	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Glaucoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Lacrimation increased	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Purtscher retinopathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Retinal detachment	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Retinal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Tolosa-Hunt syndrome	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Eye disorders Vitreous haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Prostatitis	0.03% 3/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.04% 4/9027 • Number of events 4 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Prostatic haemorrhage	0.01% 1/9010 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.03% 3/9027 • Number of events 3 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Testicular pain	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Pelvic haematoma	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Pelvic pain	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Prostatic disorder	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Endocrine disorders Goitre	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Endocrine disorders Hyperthyroidism	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Endocrine disorders Hypoaldosteronism	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Endocrine disorders Hypothyroidism	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Product Issues Device occlusion	0.01% 1/9010 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Product Issues Device dislocation	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Social circumstances Loss of personal independence in daily activities	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.02% 2/9027 • Number of events 2 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Social circumstances Victim of abuse	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Social circumstances Physical disability	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Congenital, familial and genetic disorders Hydrocele	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Congenital, familial and genetic disorders Lymphatic malformation	0.00% 0/9010 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.01% 1/9027 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).
Surgical and medical procedures Assisted suicide	0.01% 1/9010 • Number of events 1 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).	0.00% 0/9027 • All AEs were collected through Day 90 and AEs related to study drug, those leading to its discontinuation, withdrawal of consent, all-cause mortality, Other AEs and all SAEs were collected up to Day 379 (Day 365+ 14 days of follow-up) All-cause mortality was monitored/assessed for the ITT population, but Serious and Other AEs were only monitored/assessed for the SAS population. The SAS included all ITT participants (with the exception of participants enrolled at site(s) excluded from analysis due to concerns regarding data integrity) who received any investigational product and analyzed based on actual treatment received. The SAS was the primary population for summarizing and reporting safety data (SAEs and Other AEs).

Other adverse events

Adverse event data not reported

Additional Information

Study Director

CSL Behring

Phone: +1 610-878-4000

Email: clinicaltrials@cslbehring.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place