Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus (NCT NCT03161483)

Last Updated: 2023-06-15

Results Overview

The primary objective is to evaluate the clinical efficacy of three doses of CC-220 (0.45 mg once per day \[QD\], 0.3 mg QD or 0.15 mg QD) compared to placebo, for the treatment of active systemic lupus erythematosus (SLE) using the SLE Responder Index at Week 24 Composite endpoint SRI(4), defined by the following criteria: - Reduction from Baseline of ≥ 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) 2K score and - No new one or more British Isles Lupus Assessment Group (BILAG) A or new (excludes A to B) 2 or more BILAG B items compared to Baseline using BILAG 2004 Index and - No worsening from Baseline defined by an increase of \< 0.30 points from Baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

289 participants

Primary outcome timeframe

Week 24

Results posted on

2023-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	PBO QD Placebo-matching treatment once a day.	0.45 mg QD Participants dosed with CC-220 at 0.45 mg once a day	0.15 mg QD Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD Participants dosed with CC-220 at 0.30 mg once a day
Placebo Controlled Phase STARTED	83	82	42	82
Placebo Controlled Phase COMPLETED	83	81	42	82
Placebo Controlled Phase NOT COMPLETED	0	1	0	0
Treatment Period STARTED	83	81	42	82
Treatment Period Going to 0.30mg After Week 24	36	0	0	0
Treatment Period Going to 0.45mg After Week 24	36	0	0	0
Treatment Period Staying on Placebo After Week 24	11	0	0	0
Treatment Period COMPLETED	73	73	39	62
Treatment Period NOT COMPLETED	10	8	3	20

Reasons for withdrawal

Reasons for withdrawal
Measure	PBO QD Placebo-matching treatment once a day.	0.45 mg QD Participants dosed with CC-220 at 0.45 mg once a day	0.15 mg QD Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD Participants dosed with CC-220 at 0.30 mg once a day
Placebo Controlled Phase Participant Withdrew Consent	0	1	0	0
Treatment Period Death	1	0	0	0
Treatment Period Adverse Event	5	2	1	11
Treatment Period Pregnancy	1	0	0	0
Treatment Period Lack of Efficacy	0	0	0	1
Treatment Period Withdrawal by Subject	2	5	2	6
Treatment Period Lost to Follow-up	0	0	0	1
Treatment Period Protocol Violation	0	0	0	1
Treatment Period Other reasons	1	1	0	0

Baseline Characteristics

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=82 Participants Participants dosed with CC-220 at 0.45 mg once a day	Total n=289 Participants Total of all reporting groups
Age, Customized < 40 years old	33 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants	25 Participants n=4 Participants	104 Participants n=21 Participants
Age, Customized >= 40 to <= 50	26 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	28 Participants n=4 Participants	90 Participants n=21 Participants
Age, Customized > 50 to < 65	19 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants	24 Participants n=4 Participants	77 Participants n=21 Participants
Age, Customized >= 65	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants	80 Participants n=4 Participants	279 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants n=5 Participants	21 Participants n=7 Participants	46 Participants n=5 Participants	33 Participants n=4 Participants	141 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants	49 Participants n=4 Participants	148 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	60 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants	61 Participants n=4 Participants	209 Participants n=21 Participants
Race/Ethnicity, Customized Not collected or reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Primary analysis based on Intent-to-treat (ITT) Population (all randomized participants who received at least one dose of investigational product) and nonresponder imputation (NRI). Participants with insufficient data for response determination at the given time point are considered nonresponders.

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
Number of Participants Who Achieve SLE Responder Index (SRI) (4) Response	29 Number of participants	20 Number of participants	33 Number of participants	44 Number of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT population. Participants with insufficient data for response determination at the given time point are considered nonresponders.

The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days regardless of severity or whether it has improved or worsened. A SLEDAI 2K score of 3 to 4 points is representative of active disease and a decrease of 1 to 2 points is considered clinically meaningful.

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
Number of Participants With SLEDAI 2K Score Improvement of ≥ 4 Points From Baseline	30 Number of participants	20 Number of participants	35 Number of participants	45 Number of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT population with Baseline CLASI activity score ≥ 10

The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and non-scarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together.

Outcome measures

Outcome measures
Measure	PBO QD n=16 Participants Placebo-matching treatment once a day.	0.15 mg QD n=11 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=18 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=19 Participants Participants dosed with CC-220 at 0.45 mg once a day
Number of Participants With a ≥ 50% Reduction in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score From Baseline, in Participants With Baseline CLASI Activity Score ≥ 10	8 Number of participants	8 Number of participants	8 Number of participants	13 Number of participants

SECONDARY outcome

Timeframe: Week 24

Population: All treated participants

The BILAG 2004 is a composite index that is based on the Classic BILAG index. It is a clinical measure of lupus disease activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity.

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
Number of Participants With no New Organ System Affected as Defined by 1 or More BILAG A or New (Excludes A to B) 2 or More BILAG B Items Compared to Baseline Using BILAG 2004 Index	65 Number of participants	38 Number of participants	59 Number of participants	70 Number of participants

SECONDARY outcome

Timeframe: Week 24

Population: All treated participants

The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
Percentage of Participants With no Worsening (Increase of < 0.30 Points From Baseline) in PGA Compared to Baseline	78.3 Percentage of participants	90.5 Percentage of participants	73.2 Percentage of participants	85.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population; Subjects with \>=2 Swollen Joints, with a baseline value and a value at the time point.

Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.

Outcome measures

Outcome measures
Measure	PBO QD n=62 Participants Placebo-matching treatment once a day.	0.15 mg QD n=33 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=54 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=56 Participants Participants dosed with CC-220 at 0.45 mg once a day
Mean Change From Baseline in Swollen Joint Count in Participants With ≥ 2 Swollen Joints at Baseline	-6.7 swollen joints Interval -7.2 to -6.2	-6.0 swollen joints Interval -6.7 to -5.3	-6.0 swollen joints Interval -6.7 to -5.2	-6.6 swollen joints Interval -7.1 to -6.1

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population; Participants with \>=2 Tender Joints, with a baseline value and a value at the time point.

Joint tenderness and swelling will be noted as "present" or "absent," with no quantitation of severity using a 28- joint count. Note: Data presented is Adjusted mean data.

Outcome measures

Outcome measures
Measure	PBO QD n=62 Participants Placebo-matching treatment once a day.	0.15 mg QD n=33 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=54 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=56 Participants Participants dosed with CC-220 at 0.45 mg once a day
Mean Change From Baseline in Tender Joint Count in Participants With ≥ 2 Tender Joints at Baseline	-7.9 tender joints Interval -8.8 to -7.0	-6.8 tender joints Interval -8.1 to -5.6	-6.7 tender joints Interval -7.7 to -5.6	-7.6 tender joints Interval -8.5 to -6.7

SECONDARY outcome

Timeframe: Week 24

Population: ITT population with a baseline value and a value at the time point.

The PGA uses a visual analog scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows: 0 = none, 1 = mild disease, 2 = moderate disease, and 3 = severe disease.

Outcome measures

Outcome measures
Measure	PBO QD n=66 Participants Placebo-matching treatment once a day.	0.15 mg QD n=38 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=63 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=70 Participants Participants dosed with CC-220 at 0.45 mg once a day
Mean Change From Baseline in PGA Score	-0.803 scores on a scale Standard Deviation 0.605	-0.805 scores on a scale Standard Deviation 0.528	-0.819 scores on a scale Standard Deviation 0.629	-0.883 scores on a scale Standard Deviation 0.546

SECONDARY outcome

Timeframe: Week 24

Population: ITT population; participants with a baseline value and a value at the time point

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The total FACIT-Fatigue score ranges from 0 to 52. Note: Data presented is Adjusted mean data.

Outcome measures

Outcome measures
Measure	PBO QD n=67 Participants Placebo-matching treatment once a day.	0.15 mg QD n=38 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=60 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=69 Participants Participants dosed with CC-220 at 0.45 mg once a day
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score	3.8 scores on a scale Interval 1.6 to 6.0	2.7 scores on a scale Interval -0.3 to 5.6	3.1 scores on a scale Interval 0.9 to 5.4	5.2 scores on a scale Interval 3.0 to 7.4

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population; Participants with Baseline OCS Dose \>= 10 mg/day Participants with insufficient data for response determination at the given time point are considered nonresponders.

\- The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to ≤ 7.5 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24 - The percentage of participants with a prednisone or equivalent dose of ≥ 10 mg/day at Baseline whose prednisone or equivalent dose has been reduced to \< 10 mg/day by Week 16 and maintained through Week 24 with no flares between Week 16 and Week 24

Outcome measures

Outcome measures
Measure	PBO QD n=31 Participants Placebo-matching treatment once a day.	0.15 mg QD n=17 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=30 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=32 Participants Participants dosed with CC-220 at 0.45 mg once a day
Percentage of Participants With Corticosteroid Reduction Week 24, <= 7.5 mg/day	3.2 Percentage of participants	0.0 Percentage of participants	3.3 Percentage of participants	0.0 Percentage of participants
Percentage of Participants With Corticosteroid Reduction Week 24, < 10 mg/day	6.5 Percentage of participants	0.0 Percentage of participants	3.3 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT Population; Participants with the Baseline OCS Dose \>= 10 mg/day, with a baseline value and a value at the time point.

Percent change from Baseline in oral corticosteroid (OCS) dose in subjects with prednisone or equivalent ≥ 10 mg/day at Baseline Note: Data presented is Adjusted mean data.

Outcome measures

Outcome measures
Measure	PBO QD n=26 Participants Placebo-matching treatment once a day.	0.15 mg QD n=17 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=25 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=30 Participants Participants dosed with CC-220 at 0.45 mg once a day
Percent Change From Baseline in Corticosteroid Reduction	-7.9 percent change from baseline Interval -13.6 to -2.2	-5.1 percent change from baseline Interval -11.9 to 1.6	-3.8 percent change from baseline Interval -9.5 to 2.0	-1.4 percent change from baseline Interval -6.4 to 3.6

SECONDARY outcome

Timeframe: Through Week 24

Population: ITT population

Standardized total oral corticosteroid (OCS) dose.

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
The Total Corticosteroid Dose From Baseline Through Week 24	1139.7 mg Standard Deviation 916.9	1101.9 mg Standard Deviation 827.1	1071.8 mg Standard Deviation 965.0	1105.5 mg Standard Deviation 969.3

SECONDARY outcome

Timeframe: from first dose to 28 days post-last dose through Week 24 (placebo-controlled phase), approximately 28 weeks total

Population: All treated participants

Number of participants who experienced a TEAE during the course of the study

Outcome measures

Outcome measures
Measure	PBO QD n=83 Participants Placebo-matching treatment once a day.	0.15 mg QD n=42 Participants Participants dosed with CC-220 at 0.15 mg once a day	0.30 mg QD n=82 Participants Participants dosed with CC-220 at 0.30 mg once a day	0.45 mg QD n=81 Participants Participants dosed with CC-220 at 0.45 mg once a day
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE Leading to Death	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE	54 Number of participants	31 Number of participants	64 Number of participants	63 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Drug-related TEAE	24 Number of participants	14 Number of participants	36 Number of participants	32 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Serious TEAE	7 Number of participants	3 Number of participants	4 Number of participants	6 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any Severe TEAE	5 Number of participants	3 Number of participants	4 Number of participants	1 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE Leading to Drug Interruption	15 Number of participants	10 Number of participants	14 Number of participants	23 Number of participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE Leading to Drug Withdrawal	6 Number of participants	2 Number of participants	11 Number of participants	4 Number of participants

Adverse Events

0.15mg QD

Serious events: 6 serious events

Other events: 32 other events

Deaths: 1 deaths

0.30mg QD

Serious events: 10 serious events

Other events: 63 other events

Deaths: 0 deaths

0.45mg QD

Serious events: 14 serious events

Other events: 62 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 34 other events

Deaths: 1 deaths

Active Treatment Phase 0.30mg Following Placebo

Serious events: 2 serious events

Other events: 16 other events

Deaths: 1 deaths

Active Treatment Phase 0.45mg Following Placebo

Serious events: 3 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	0.15mg QD n=42 participants at risk Participants dosed with CC-220 at 0.15 mg once a day	0.30mg QD n=82 participants at risk Participants dosed with CC-220 at 0.30 mg once a day	0.45mg QD n=81 participants at risk Participants dosed with CC-220 at 0.45 mg once a day	Placebo n=83 participants at risk Placebo-matching treatment once a day.	Active Treatment Phase 0.30mg Following Placebo n=36 participants at risk Participants dosed with CC-220 at 0.30 mg once a day	Active Treatment Phase 0.45mg Following Placebo n=36 participants at risk Participants dosed with CC-220 at 0.45 mg once a day
Blood and lymphatic system disorders Anaemia	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac arrest	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Cardiac tamponade	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders Pericarditis	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Tinnitus	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diverticular perforation	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Implant site pain	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Influenza like illness	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholangitis	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders Cholelithiasis	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Abscess limb	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bronchitis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19 pneumonia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Escherichia urinary tract infection	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Gastroenteritis viral	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Lower respiratory tract infection	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pneumonia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Septic shock	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection enterococcal	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Varicella zoster pneumonia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Joint injury	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Radius fracture	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Suture related complication	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Traumatic fracture	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 3/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Brain stem infarction	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Encephalopathy	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hemiparesis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Ischaemic stroke	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Polyneuropathy	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Panic attack	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Nephrotic syndrome	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Proteinuria	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Abnormal uterine bleeding	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Endometriosis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Deep vein thrombosis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertensive crisis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Other adverse events
Measure	0.15mg QD n=42 participants at risk Participants dosed with CC-220 at 0.15 mg once a day	0.30mg QD n=82 participants at risk Participants dosed with CC-220 at 0.30 mg once a day	0.45mg QD n=81 participants at risk Participants dosed with CC-220 at 0.45 mg once a day	Placebo n=83 participants at risk Placebo-matching treatment once a day.	Active Treatment Phase 0.30mg Following Placebo n=36 participants at risk Participants dosed with CC-220 at 0.30 mg once a day	Active Treatment Phase 0.45mg Following Placebo n=36 participants at risk Participants dosed with CC-220 at 0.45 mg once a day
Blood and lymphatic system disorders Anaemia	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.4% 6/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Leukopenia	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 10/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Lymphopenia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Neutropenia	4.8% 2/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.8% 8/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	19.8% 16/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain upper	4.8% 2/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 3/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	14.3% 6/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.9% 8/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 5/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	14.3% 6/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Bronchitis	9.5% 4/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 5/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 3/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Gastroenteritis	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Influenza	9.5% 4/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	9.9% 8/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 3/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Nasopharyngitis	11.9% 5/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.5% 7/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.3% 10/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	11.1% 4/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Oral herpes	9.5% 4/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 2/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Pharyngitis	11.9% 5/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	7.3% 6/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sinusitis	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.1% 5/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 5/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	14.3% 6/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	13.4% 11/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.5% 15/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.8% 4/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 6/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	16.7% 7/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	29.3% 24/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	18.5% 15/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.6% 3/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	16.7% 6/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Limb injury	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 2/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypertriglyceridaemia	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 2/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	4.8% 2/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 5/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Osteoarthritis	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	7.1% 3/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	3.7% 3/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.0% 5/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Hypoaesthesia	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.5% 2/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.8% 1/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	1.2% 1/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	4.8% 2/42 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	4.9% 4/82 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	6.2% 5/81 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	2.4% 2/83 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	5.6% 2/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	8.3% 3/36 • The number at Risk for All-Cause Mortality represents all Randomized Participants; From date of randomization to 100 days post last dose. Approximately Up to 47 Months The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication; 28 days post last dose Approximately up to 48 months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60