Trial Outcomes & Findings for An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis (NCT NCT03611751)

NCT ID: NCT03611751

Last Updated: 2022-12-20

Results Overview

The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method. Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1020 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2022-12-20

Participant Flow

1 Participant stopped treatment after week 16 and re-entered in treatment period Week 24-52.

Participant milestones

Measure	BMS-986165 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Pre-treatment STARTED	511	255	254
Pre-treatment COMPLETED	510	254	254
Pre-treatment NOT COMPLETED	1	1	0
Treatment Week 0 - Week 16 STARTED	510	254	254
Treatment Week 0 - Week 16 COMPLETED	456	212	217
Treatment Week 0 - Week 16 NOT COMPLETED	54	42	37
Treatment Week 16 - Week 24 STARTED	667	0	217
Treatment Week 16 - Week 24 COMPLETED	642	0	208
Treatment Week 16 - Week 24 NOT COMPLETED	25	0	9
Treatment Week 24 - Week 52 STARTED	604	247	0
Treatment Week 24 - Week 52 COMPLETED	535	214	0
Treatment Week 24 - Week 52 NOT COMPLETED	69	33	0

Reasons for withdrawal

Measure	BMS-986165 Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Pre-treatment Randomized but not treated	1	1	0
Treatment Week 0 - Week 16 Adverse Event	11	7	12
Treatment Week 0 - Week 16 Lack of Efficacy	6	9	4
Treatment Week 0 - Week 16 Lost to Follow-up	5	6	2
Treatment Week 0 - Week 16 Non-compliance with protocol	5	2	1
Treatment Week 0 - Week 16 Withdrawal by Subject	14	9	9
Treatment Week 0 - Week 16 Other reasons	13	9	7
Treatment Week 0 - Week 16 Pregnancy	0	0	1
Treatment Week 0 - Week 16 Death	0	0	1
Treatment Week 16 - Week 24 Adverse Event	7	0	2
Treatment Week 16 - Week 24 Lack of Efficacy	8	0	1
Treatment Week 16 - Week 24 Lost to Follow-up	2	0	0
Treatment Week 16 - Week 24 Non-compliance with protocol	3	0	1
Treatment Week 16 - Week 24 Withdrawal by Subject	2	0	1
Treatment Week 16 - Week 24 Other reasons	2	0	3
Treatment Week 16 - Week 24 Pregnancy	1	0	1
Treatment Week 24 - Week 52 Adverse Event	14	7	0
Treatment Week 24 - Week 52 Lack of Efficacy	8	8	0
Treatment Week 24 - Week 52 Lost to Follow-up	9	4	0
Treatment Week 24 - Week 52 Non-compliance with protocol	2	0	0
Treatment Week 24 - Week 52 Withdrawal by Subject	8	6	0
Treatment Week 24 - Week 52 Other reasons	28	7	0
Treatment Week 24 - Week 52 Pregnancy	0	1	0

Baseline Characteristics

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=254 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.	Total n=1020 Participants Total of all reporting groups
Age, Continuous	46.9 Years STANDARD_DEVIATION 13.37 • n=5 Participants	47.3 Years STANDARD_DEVIATION 13.57 • n=7 Participants	46.4 Years STANDARD_DEVIATION 13.28 • n=5 Participants	46.9 Years STANDARD_DEVIATION 13.39 • n=4 Participants
Sex: Female, Male Female	175 Participants n=5 Participants	74 Participants n=7 Participants	97 Participants n=5 Participants	346 Participants n=4 Participants
Sex: Female, Male Male	336 Participants n=5 Participants	181 Participants n=7 Participants	157 Participants n=5 Participants	674 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=5 Participants	29 Participants n=7 Participants	29 Participants n=5 Participants	116 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	445 Participants n=5 Participants	226 Participants n=7 Participants	223 Participants n=5 Participants	894 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized White	474 Participants n=5 Participants	232 Participants n=7 Participants	229 Participants n=5 Participants	935 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	26 Participants n=4 Participants
Race/Ethnicity, Customized Asian	24 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants	44 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 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
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All randomized participants in the BMS-986165 and Placebo arms

The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least a 2-point improvement from baseline using the non-responder imputation (NRI) method.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)	253 Participants	22 Participants	—

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants in the BMS-986165 and Placebo arms

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)	271 Participants	24 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=254 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 90)	138 Participants	7 Participants	46 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the response as a number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=254 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 100% Improvement From Baseline in the Psoriasis Area and Severity Index Score at Week 16 (PASI 100)	52 Participants	3 Participants	11 Participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants

The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 using the non-responder imputation (NRI) method.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=255 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=254 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Static Physician Global Assessment Score of 0 at Week 16 (sPGA 0)	80 Participants	3 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants with evaluable baseline and week 16 PSSD scores.

PSSD assesses the severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). Both symptom and sign scores are derived by averaging the questions and multiplying by 10. A total PSSD score ranging 0-100 will be derived from taking the average of the symptom and sign scores. 0 represents the least severe symptom/sign and 100 represents the most severe. Baseline is defined as the measurement at the randomization visit (Week 0).

A modified observation carried forward (mBOCF) approach will be used for missing data. The baseline observation will be carried forward for participants who discontinue study treatment for all analysis weeks after the assessment time point of discontinuation due to lack of efficacy and AEs.

Outcome measures

Measure	BMS-986165 n=466 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=239 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=233 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Change From Baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score at Week 16	-28.9 Score on a scale Standard Deviation 25.22	-4.2 Score on a scale Standard Deviation 19.58	-21.5 Score on a scale Standard Deviation 25.44

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline PSSD symptom score ≥ 1

Psoriasis Symptoms and Signs Diary (PSSD) is an 11-item participant-reported instrument that assesses severity of symptoms and participant-observed signs commonly associated in plaque psoriasis. The PSSD assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 participant-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) using 0 to 10 numerical ratings. The severity of each item is rated on an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable) where the symptoms summary score is derived from the average of the scores. A higher score indicates more severe disease. PSSD 0 is the response as a number of participants who experience a PSSD symptom score that determines psoriasis severity as 0 among participants with a baseline PSSD symptom score >= 1 using the non-responder imputation (NRI) method.

Outcome measures

Measure	BMS-986165 n=466 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=238 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=232 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 at Week 16	35 Participants	3 Participants	10 Participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline ss-PGA score \>=3

The scalp specific Physician's Global Assessment (ss-PGA) evaluates scalp lesions in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. ss-PGA 0/1 is the response as a number of participants who experience a ss-PGA score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline ss-PGA score ≥3 .

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=305 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=173 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=166 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Scalp Specific Physician's Global Assessment (Ss-PGA) Score 0 or 1 at Week 16 (Ss-PGA 0/1)	182 Participants	30 Participants	61 Participants

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline DLQI score \>=2. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.

The DLQI is a participant-reported quality of life index which consists of 10 questions concerning how much skin problems affect symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a scale of 0 to 3 where 0 = not at all, 1 =a little, 2 = a lot, or 3 = very much. The scores are summed, giving a range from 0 (no impairment of life quality) to 30 (maximum impairment). DLQI 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline DLQI score ≥2.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=495 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=246 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Dermatology Life Quality Index (DLQI) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (DLQI 0/1)	186 Participants	24 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline PGA-F score \>=3. Pre-specified for data to be collected only in BMS-986165 and Placebo arms.

The Physician Global Assessment- Fingernails (PGA-F) evaluates the overall condition of the fingernails and is rated on a 5-point scale:0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe. PGA-F 0/1 is the response as a number of participants with a PGA-F score of 0 or 1 with at least a 2-point improvement from baseline among participants with a baseline PGA-F score >=3.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=69 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=38 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Physician Global Assessment- Fingernails (PGA-F) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PGA-F 0/1)	14 Participants	3 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants with a baseline pp-PGA score \>=3.

The palmoplantar Physician's Global Assessment (pp-PGA) score evaluates palmoplantar (including finger and toe surfaces) psoriasis lesions based on overall severity by investigator, then scored on the following 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; and 4 = severe. pp-PGA 0/1 is the number of participants with a score of 0 or 1 among participants with a baseline pp-PGA score ≥ 3.

Outcome measures

Measure	BMS-986165 n=39 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=17 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=20 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Palmoplantar Physician's Global Assessment (Pp-PGA) Score of 0 or 1 at Week 16 (Pp-PGA 0/1)	18 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All randomized participants in the BMS-986165 and Apremilast arms.

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

The PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=254 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (PASI 75)	271 Participants	101 Participants	—

SECONDARY outcome

Timeframe: Week 16

Population: All randomized participants in the BMS-986165 and Apremilast arms.

The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1 with at least a 2-point improvement from baseline.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 16 or who have missing Week 16 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=511 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=254 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremilast at Week 16 (sPGA 0/1)	253 Participants	86 Participants	—

SECONDARY outcome

Timeframe: From Week 24 to Week 52 (up to approximately 28 weeks)

Population: All randomized participants who had PASI 75 response at week 24. Pre-specified to report participants from their original randomization.

Relapse is defined as 50% loss or greater of Week 24 PASI percent improvement from baseline.

The PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity.

Outcome measures

Measure	BMS-986165 n=145 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=150 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast n=95 Participants Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
Time to Relapse Until Week 52 Among Week 24 PASI 75 Responders	NA Days Insufficient number of participants with events	NA Days Insufficient number of participants with events	197.0 Days Interval 125.0 to Insufficient number of participants with events

SECONDARY outcome

Timeframe: Week 24

Population: All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

The sPGA is a 5-point scale average assessment of all psoriatic lesions graded for erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as: clear (0), almost clear (1), mild (2), moderate (3), or severe (4). The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. sPGA 0/1 is the number of participants with a sPGA score of 0 or 1.

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=504 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=254 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants With a Static Physician Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (sPGA 0/1)	251 Participants	75 Participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=504 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=254 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Apremalist at Week 24 (PASI 75)	296 Participants	96 Participants	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: All randomized participants. Pre-specified for data to be collected only in the BMS-986165 and Apremilast arms and from participants original randomization. Participants who had any visit impacted by COVID will be excluded from that visit.

The Psoriasis Area and Severity Index (PASI) is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance.

PASI is a measure of the average erythema (redness), infiltration (thickness), and desquamation (scaling) of psoriatic skin lesions (each graded on a 0-4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the response as a number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method. Baseline is defined as the measurement at the randomization visit (Week 0).

Non-responder imputation (NRI) will be used for participants who: Discontinue treatment or study prior to Week 24 or who have missing Week 24 endpoint data for any reason.

Outcome measures

Measure	BMS-986165 n=504 Participants Participants receive 6 mg of BMS-986165 by oral administration once daily (QD). Participants originally randomized to BMS-986165 who are PASI 75 responders at Week 24 are re-randomized to BMS-986165 or placebo. Nonresponders at Week 24 will continue to receive BMS-986165 at Week 24.	Placebo n=254 Participants Participants receive Placebo by oral administration once daily (QD). Participants originally randomized to placebo switch to BMS-986165 at Week 16.	Apremilast Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) * 10 mg used for titration Day 1 through Day 3 morning dose * 20 mg used for titration Day 3 evening dose through Day 5 morning dose. * 30 mg from Day 5 evening dose onwards. Participants originally randomized to apremilast who are PASI 75 responders at Week 24 are switched to placebo at Week 24. Nonresponders at Week 24 are switched to BMS-986165 at Week 24.
The Number of Participants Who Achieve a 90% Improvement From Baseline in the Psoriasis Area and Severity Index Score in Participants Receiving BMS-986165 Compared to Apremilast at Week 24 (PASI 90)	164 Participants	50 Participants	—

Adverse Events

BMS-986165 (Week 0 up to Week 16)

Serious events: 8 serious events

Other events: 114 other events

Deaths: 1 deaths

Placebo (Week 0 up to Week 16)

Serious events: 3 serious events

Other events: 61 other events

Deaths: 0 deaths

Apremilast (Week 0 up to Week 16)

Serious events: 1 serious events

Other events: 86 other events

Deaths: 1 deaths

BMS-986165 (Week 0 up to Week 52)

Serious events: 24 serious events

Other events: 249 other events

Deaths: 2 deaths

Placebo (Week 0 up to Week 52)

Serious events: 5 serious events

Other events: 97 other events

Deaths: 0 deaths

Apremilast (Week 0 up to Week 52)

Serious events: 3 serious events

Other events: 98 other events

Deaths: 1 deaths

Serious adverse events

Measure	BMS-986165 (Week 0 up to Week 16) n=510 participants at risk Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Placebo (Week 0 up to Week 16) n=254 participants at risk Participants receive Placebo by oral administration once daily (QD)	Apremilast (Week 0 up to Week 16) n=254 participants at risk Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards	BMS-986165 (Week 0 up to Week 52) n=833 participants at risk Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Placebo (Week 0 up to Week 52) n=501 participants at risk Participants receive Placebo by oral administration once daily (QD)	Apremilast (Week 0 up to Week 52) n=254 participants at risk Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Atrial fibrillation	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 failure	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Myocardial ischaemia	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Pericardial effusion	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Congenital, familial and genetic disorders Gastrointestinal arteriovenous malformation	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Retinal detachment	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Anal polyp	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Gastrointestinal haemorrhage	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Pancreatic mass	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Hepatitis	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Immune system disorders Anaphylactic reaction	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Anal abscess	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Diverticulitis	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Mycoplasma infection	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.36% 3/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Purulence	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Sepsis	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Streptococcal bacteraemia	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Vascular graft infection	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Post procedural haemorrhage	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Dehydration	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Diabetes mellitus	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Cerebrovascular accident	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Major depression	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Ovarian cyst	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Acute respiratory failure	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Nasal septum deviation	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Respiratory failure	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Excessive granulation tissue	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Malignant hypertension	0.20% 1/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Peripheral artery occlusion	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.39% 1/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.20% 1/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Shock	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Thrombosis	0.00% 0/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.12% 1/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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

Measure	BMS-986165 (Week 0 up to Week 16) n=510 participants at risk Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Placebo (Week 0 up to Week 16) n=254 participants at risk Participants receive Placebo by oral administration once daily (QD)	Apremilast (Week 0 up to Week 16) n=254 participants at risk Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards	BMS-986165 (Week 0 up to Week 52) n=833 participants at risk Participants receive 6 mg of BMS-986165 by oral administration once daily (QD)	Placebo (Week 0 up to Week 52) n=501 participants at risk Participants receive Placebo by oral administration once daily (QD)	Apremilast (Week 0 up to Week 52) n=254 participants at risk Participants receive 30 mg of Apremilast by oral administration twice daily (BID) (with initial titration per label) 10 mg used for titration Day 1 through Day 3 morning dose 20 mg used for titration Day 3 evening dose through Day 5 morning dose. 30 mg from Day 5 evening dose onwards
Gastrointestinal disorders Diarrhoea	4.7% 24/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.5% 19/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.0% 33/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.7% 39/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 22/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	13.8% 35/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	1.4% 7/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 3/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 23/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.6% 13/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 6/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.2% 26/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	10.8% 55/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.4% 29/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.1% 23/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.0% 133/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 47/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.0% 28/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	4.9% 25/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.3% 11/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.5% 14/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.9% 74/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 27/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 21/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	4.3% 22/510 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.5% 14/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.0% 28/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.4% 45/833 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.2% 16/501 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.8% 30/254 • Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 60 weeks). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 56 weeks) The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER