Trial Outcomes & Findings for Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (NCT NCT04564547)

NCT ID: NCT04564547

Last Updated: 2026-01-26

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 161 participants
• Primary outcome timeframe: Up to approximately 9 months
• Results posted on: 2026-01-26

Participant Flow

As pre-specified in protocol amendment 2, participants in the Double-blind Treatment Period discontinued all study interventions (islatravir [ISL], ulonivirine, or bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]). Participants who received ISL + ulonivirine may have then entered the Unblinded Safety Monitoring Period and received standard of care non-study antiretroviral therapy (ART), provided by the investigator, until study completion or discontinuation.

Participant milestones

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 2: ISL 20 mg + Ulonivirine 200 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 3: ISL 20 mg + Ulonivirine 400 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 4: BIC/FTC/TAF In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD until study-wide discontinuation of study intervention.
Double-blind Treatment Period STARTED	40	41	40	40
Double-blind Treatment Period COMPLETED	37	39	38	39
Double-blind Treatment Period NOT COMPLETED	3	2	2	1
Unblinded Safety Monitoring Period STARTED	37	39	37	0
Unblinded Safety Monitoring Period COMPLETED	25	25	24	0
Unblinded Safety Monitoring Period NOT COMPLETED	12	14	13	0

Reasons for withdrawal

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 2: ISL 20 mg + Ulonivirine 200 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 3: ISL 20 mg + Ulonivirine 400 mg In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 4: BIC/FTC/TAF In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD until study-wide discontinuation of study intervention.
Double-blind Treatment Period Lost to Follow-up	0	0	1	1
Double-blind Treatment Period Physician Decision	0	1	1	0
Double-blind Treatment Period Withdrawal by Subject	3	1	0	0
Unblinded Safety Monitoring Period Lost to Follow-up	0	1	1	0
Unblinded Safety Monitoring Period Physician Decision	1	0	1	0
Unblinded Safety Monitoring Period Sponsor Decision	5	6	4	0
Unblinded Safety Monitoring Period Withdrawal by Subject	6	7	7	0

Baseline Characteristics

Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

Baseline characteristics by cohort

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD). Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 2: ISL 20 mg + Ulonivirine 200 mg n=41 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 3: ISL 20 mg + Ulonivirine 400 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD. Following study-wide discontinuation of study intervention, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	Group 4: BIC/FTC/TAF n=40 Participants In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD until study-wide discontinuation of study intervention.	Total n=161 Participants Total of all reporting groups
Age, Continuous	43.7 Years STANDARD_DEVIATION 12.1 • n=25 Participants	46.5 Years STANDARD_DEVIATION 10.8 • n=25 Participants	43.5 Years STANDARD_DEVIATION 12.6 • n=50 Participants	47.9 Years STANDARD_DEVIATION 11.6 • n=152 Participants	45.4 Years STANDARD_DEVIATION 11.8 • n=614 Participants
Sex: Female, Male Female	9 Participants n=25 Participants	8 Participants n=25 Participants	6 Participants n=50 Participants	8 Participants n=152 Participants	31 Participants n=614 Participants
Sex: Female, Male Male	31 Participants n=25 Participants	33 Participants n=25 Participants	34 Participants n=50 Participants	32 Participants n=152 Participants	130 Participants n=614 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=25 Participants	8 Participants n=25 Participants	6 Participants n=50 Participants	8 Participants n=152 Participants	28 Participants n=614 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=25 Participants	30 Participants n=25 Participants	32 Participants n=50 Participants	32 Participants n=152 Participants	124 Participants n=614 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=25 Participants	3 Participants n=25 Participants	2 Participants n=50 Participants	0 Participants n=152 Participants	9 Participants n=614 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants	2 Participants n=614 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	2 Participants n=25 Participants	0 Participants n=50 Participants	1 Participants n=152 Participants	3 Participants n=614 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants	0 Participants n=614 Participants
Race (NIH/OMB) Black or African American	10 Participants n=25 Participants	14 Participants n=25 Participants	13 Participants n=50 Participants	13 Participants n=152 Participants	50 Participants n=614 Participants
Race (NIH/OMB) White	27 Participants n=25 Participants	24 Participants n=25 Participants	27 Participants n=50 Participants	26 Participants n=152 Participants	104 Participants n=614 Participants
Race (NIH/OMB) More than one race	1 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants	1 Participants n=614 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	1 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=152 Participants	1 Participants n=614 Participants

PRIMARY outcome

Timeframe: Up to approximately 9 months

Population: All randomized participants who received at least 1 dose of double-blind study intervention

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and supplemental statistical analysis plan (sSAP), presented here is the percentage of participants who experienced one or more AEs during the Double-blind Treatment Period and includes the 42 days following the final dose of double-blind study intervention.

Outcome measures

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg QW and placebo to BIC/FTC/TAF QD.	Group 2: ISL 20 mg + Ulonivirine 200 mg n=41 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD.	Group 3: ISL 20 mg + Ulonivirine 400 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD.	Group 4: BIC/FTC/TAF n=40 Participants In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.
Percentage of Participants Who Experienced One or More Adverse Events (AEs) During the Double-Blind Treatment Period +42 Days Post-Blind	75.0 Percentage of Participants	75.6 Percentage of Participants	80.0 Percentage of Participants	67.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 8 months

Population: All randomized participants who received at least 1 dose of double-blind study intervention

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who discontinued double-blind study intervention due to an AE during the Double-Blind Treatment Period.

Outcome measures

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg QW and placebo to BIC/FTC/TAF QD.	Group 2: ISL 20 mg + Ulonivirine 200 mg n=41 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD.	Group 3: ISL 20 mg + Ulonivirine 400 mg n=40 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD.	Group 4: BIC/FTC/TAF n=40 Participants In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.
Percentage of Participants Who Discontinued Study Intervention Due to an AE During the Double-Blind Treatment Period	0.0 Percentage of Participants	4.9 Percentage of Participants	2.5 Percentage of Participants	0.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to approximately 37 months

Population: All randomized participants who received at least 1 dose of double-blind study intervention and entered into the Unblinded Safety Monitoring Period

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified in the protocol and sSAP, presented here is the percentage of participants who experienced one or more AEs during the Unblinded Safety Monitoring Period, beginning 42 days following the final dose of double-blind study intervention.

Outcome measures

Measure	Group 1: ISL 20 mg + Ulonivirine 100 mg n=37 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg QW and placebo to BIC/FTC/TAF QD.	Group 2: ISL 20 mg + Ulonivirine 200 mg n=39 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD.	Group 3: ISL 20 mg + Ulonivirine 400 mg n=37 Participants In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD.	Group 4: BIC/FTC/TAF In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.
Percentage of Participants Who Experienced One or More AEs During the Unblinded Safety Monitoring Period	56.8 Percentage of Participants	56.4 Percentage of Participants	67.6 Percentage of Participants	—

Adverse Events

ISL 20 mg + MK-8507 100 mg QW

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

ISL 20 mg + MK-8507 200 mg QW

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

ISL 20 mg + MK-8507 400 mg QW

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

BIC/FTC/TAF QD

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ISL 20 mg + MK-8507 100 mg QW → Non-study ART

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

ISL 20 mg + MK-8507 200 mg QW → Non-study ART

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

ISL 20 mg + MK-8507 400 mg QW → Non-study ART

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	ISL 20 mg + MK-8507 100 mg QW n=40 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD).	ISL 20 mg + MK-8507 200 mg QW n=41 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD.	ISL 20 mg + MK-8507 400 mg QW n=40 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD.	BIC/FTC/TAF QD n=40 participants at risk In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.	ISL 20 mg + MK-8507 100 mg QW → Non-study ART n=37 participants at risk After receiving ISL 20 mg + ulonivirine 100 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	ISL 20 mg + MK-8507 200 mg QW → Non-study ART n=39 participants at risk After receiving ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	ISL 20 mg + MK-8507 400 mg QW → Non-study ART n=37 participants at risk After receiving ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.
Cardiac disorders Acute myocardial infarction	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
General disorders Device related thrombosis	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
General disorders Non-cardiac chest pain	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Campylobacter gastroenteritis	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Cellulitis	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Renal and urinary disorders Renal colic	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.

Other adverse events

Measure	ISL 20 mg + MK-8507 100 mg QW n=40 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD).	ISL 20 mg + MK-8507 200 mg QW n=41 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD.	ISL 20 mg + MK-8507 400 mg QW n=40 participants at risk In the Double-blind Treatment Period, participants received ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD.	BIC/FTC/TAF QD n=40 participants at risk In the Double-blind Treatment Period, participants received placebo to ISL + placebo to ulonivirine QW and BIC/FTC/TAF 50 mg/200 mg/25 mg QD.	ISL 20 mg + MK-8507 100 mg QW → Non-study ART n=37 participants at risk After receiving ISL 20 mg + ulonivirine 100 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	ISL 20 mg + MK-8507 200 mg QW → Non-study ART n=39 participants at risk After receiving ISL 20 mg + ulonivirine 200 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.	ISL 20 mg + MK-8507 400 mg QW → Non-study ART n=37 participants at risk After receiving ISL 20 mg + ulonivirine 400 mg QW and placebo to BIC/FTC/TAF QD in the Double-blind Treatment Period, participants may have entered the optional Unblinded Safety Monitoring Period and received standard of care non-study ART.
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.5% 3/40 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.3% 3/41 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	15.0% 6/40 • Number of events 7 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.4% 2/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Gastrointestinal disorders Nausea	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	4.9% 2/41 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	10.0% 4/40 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
General disorders Asthenia	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.3% 3/41 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
General disorders Fatigue	10.0% 4/40 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.3% 3/41 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	12.5% 5/40 • Number of events 6 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.4% 2/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
General disorders Oedema peripheral	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Bronchitis	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	4.9% 2/41 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations COVID-19	7.5% 3/40 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	9.8% 4/41 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	17.5% 7/40 • Number of events 7 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.5% 3/40 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	10.8% 4/37 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	17.9% 7/39 • Number of events 7 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	29.7% 11/37 • Number of events 11 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Gastroenteritis	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Nasopharyngitis	5.0% 2/40 • Number of events 3 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	7.5% 3/40 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.6% 1/39 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Sinusitis	7.5% 3/40 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.4% 2/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Infections and infestations Syphilis	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Injury, poisoning and procedural complications Accidental overdose	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	4.9% 2/41 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	10.0% 4/40 • Number of events 6 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	12.5% 5/40 • Number of events 10 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Metabolism and nutrition disorders Obesity	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/41 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Musculoskeletal and connective tissue disorders Arthralgia	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.4% 2/37 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Musculoskeletal and connective tissue disorders Back pain	2.5% 1/40 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	10.0% 4/40 • Number of events 4 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.0% 2/40 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	5.1% 2/39 • Number of events 2 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.7% 1/37 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.
Nervous system disorders Headache	12.5% 5/40 • Number of events 6 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	2.4% 1/41 • Number of events 1 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	10.0% 4/40 • Number of events 7 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/40 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/39 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.	0.00% 0/37 • Up to approximately 46 months (Double-blind Treatment Period: AEs were assessed at the participant level for up to approximately 9 months [from randomization to 42 days after last double-blind study intervention]; Unblinded Safety Monitoring Period: AEs were assessed at the participant level for up to approximately 37 months [beginning 42 days after the final double-blind study intervention to last participant data collection]) All-Cause Mortality is reported for all randomized participants. Serious AEs and Other AEs are reported for all randomized participants who received at least 1 dose of study treatment. Double-blind Treatment Period arms include all events occurring up to 42 days following the final dose of double-blind study intervention. Unblinded Safety Monitoring Period arms include all events from 42 days after the final double-blind study intervention to study completion.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@msd.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts and manuscripts regarding this trial prior to submission for publication. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multi-center studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
• Publication restrictions are in place

Restriction type: OTHER