Trial Outcomes & Findings for Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (NCT NCT03272347)

Last Updated: 2023-03-29

Results Overview

Blood samples were collected and plasma human immunodeficiency virus 1 (HIV-1) ribonucleic acid (RNA) were quantified using a real time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

Week 24

Results posted on

2023-03-29

Participant Flow

Treatment-naïve participants ≥18 years of age with human immunodeficiency virus type 1 (HIV-1) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Islatravir 0.25 mg In Part 1, participants were treated once daily (QD) with 0.25 mg islatravir, 100 mg doravirine (DOR), 300 mg lamivudine (3TC), and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no Protocol-defined Virologic Failure (PDVF) discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.
Overall Study STARTED	31	30	31	31
Overall Study Treated	29	30	31	31
Overall Study COMPLETED	20	24	19	24
Overall Study NOT COMPLETED	11	6	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Islatravir 0.25 mg In Part 1, participants were treated once daily (QD) with 0.25 mg islatravir, 100 mg doravirine (DOR), 300 mg lamivudine (3TC), and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no Protocol-defined Virologic Failure (PDVF) discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.
Overall Study Death	0	0	0	1
Overall Study Lost to Follow-up	1	3	5	1
Overall Study Physician Decision	4	2	5	4
Overall Study Screen Failure	1	0	0	0
Overall Study Withdrawal by Subject	5	1	2	1

Baseline Characteristics

Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Islatravir 0.25 mg n=31 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Total n=123 Participants Total of all reporting groups
Age, Continuous	32.3 Years STANDARD_DEVIATION 13.3 • n=31 Participants	30.0 Years STANDARD_DEVIATION 9.0 • n=30 Participants	32.4 Years STANDARD_DEVIATION 11.8 • n=31 Participants	29.4 Years STANDARD_DEVIATION 8.9 • n=31 Participants	31.0 Years STANDARD_DEVIATION 10.9 • n=123 Participants
Sex: Female, Male Female	1 Participants n=31 Participants	3 Participants n=30 Participants	3 Participants n=31 Participants	3 Participants n=31 Participants	10 Participants n=123 Participants
Sex: Female, Male Male	30 Participants n=31 Participants	27 Participants n=30 Participants	28 Participants n=31 Participants	28 Participants n=31 Participants	113 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=31 Participants	19 Participants n=30 Participants	12 Participants n=31 Participants	15 Participants n=31 Participants	60 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=31 Participants	11 Participants n=30 Participants	18 Participants n=31 Participants	15 Participants n=31 Participants	60 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=31 Participants	1 Participants n=31 Participants	3 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	1 Participants n=31 Participants	1 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	6 Participants n=31 Participants	6 Participants n=30 Participants	8 Participants n=31 Participants	5 Participants n=31 Participants	25 Participants n=123 Participants
Race (NIH/OMB) White	24 Participants n=31 Participants	24 Participants n=30 Participants	21 Participants n=31 Participants	24 Participants n=31 Participants	93 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	0 Participants n=30 Participants	2 Participants n=31 Participants	0 Participants n=31 Participants	2 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=31 Participants	1 Participants n=31 Participants	2 Participants n=123 Participants
CD4+ T-Cell Count	450.8 cells/mm^3 STANDARD_DEVIATION 170.0 • n=29 Participants • Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.	538.5 cells/mm^3 STANDARD_DEVIATION 165.5 • n=30 Participants • Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.	469.6 cells/mm^3 STANDARD_DEVIATION 203.3 • n=31 Participants • Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.	508.5 cells/mm^3 STANDARD_DEVIATION 206.8 • n=31 Participants • Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.	492.1 cells/mm^3 STANDARD_DEVIATION 188.5 • n=121 Participants • Two untreated participants from the Islatravir 0.25 mg treatment group were not analyzed.
Participants with <=100,000 copies/mL of HIV-1 RNA	24 Participants n=31 Participants	23 Participants n=30 Participants	23 Participants n=31 Participants	24 Participants n=31 Participants	94 Participants n=123 Participants
Participants with >100,000 copies/mL of HIV-1 RNA	7 Participants n=31 Participants	7 Participants n=30 Participants	8 Participants n=31 Participants	7 Participants n=31 Participants	29 Participants n=123 Participants

PRIMARY outcome

Timeframe: Week 24

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 24	90.3 Percentage of participants	90.3 Percentage of participants	93.1 Percentage of participants	100.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 48

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48	77.4 Percentage of participants	83.9 Percentage of participants	89.7 Percentage of participants	90.0 Percentage of participants	—	—

PRIMARY outcome

Timeframe: Up to 144 weeks

Population: All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Experiencing Adverse Events (AEs) up to Week 144	24 Participants	27 Participants	26 Participants	27 Participants	—	—

PRIMARY outcome

Timeframe: Up to 144 weeks

Population: All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Discontinuing Study Drug Due to AEs up to Week 144	2 Participants	1 Participants	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks after 3TC and Placebo are discontinued from the regimen (up to approximately 60 weeks after initiating treatment)

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL, and missing values were counted as failure. 3TC and placebo are discontinued from the regimen from Week 24 up to Week 52.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=27 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=28 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen	88.9 Percentage of participants	96.4 Percentage of participants	86.2 Percentage of participants	90.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Up to 48 weeks

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=27 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=28 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After 3TC and Placebo Are Discontinued From the Regimen	59.3 Percentage of participants	60.7 Percentage of participants	62.1 Percentage of participants	56.7 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Up to Week 192

Population: Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data were analyzed.

Blood samples were collected and plasma HIV-1 RNA were quantified using a real time PCR assay with a lower limit of detection of 40 copies/mL. Missing values were counted as failure. The percentage of participants with HIV-1 RNA \<50 copies in Part 4 are reported.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=67 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=22 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Percentage of Participants With HIV-1 RNA <50 Copies/mL up to 48 Weeks After Starting Open-label Doravirine/Islatravir Regimen (Part 4)	—	—	85.1 Percentage of participants	95.5 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Blood samples were collected and cluster of differentiation (CD4)+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Change From Baseline in Mature T-helper (CD4+ T)-Cell Count at Week 24	142.9 cells/mm^3 Interval 89.9 to 196.0	142.1 cells/mm^3 Interval 105.7 to 178.5	220.5 cells/mm^3 Interval 170.3 to 270.8	192.8 cells/mm^3 Interval 117.9 to 267.7	—	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Day 1 value, and baseline values were carried forward for participants who discontinue due to lack of efficacy. Post-baseline data were collected after the first dose of study medication through 14 days after the last dose of study medication.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Change From Baseline in CD4+ T-cell Count at Week 48	100.7 cells/mm^3 Interval 25.0 to 176.3	181.4 cells/mm^3 Interval 137.2 to 225.6	182.0 cells/mm^3 Interval 119.6 to 244.5	183.0 cells/mm^3 Interval 124.7 to 241.2	—	—

SECONDARY outcome

Timeframe: Baseline and Week 96

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Change From Baseline in CD4+ T-cell Count at Week 96	136.5 cells/mm^3 Interval 57.0 to 216.0	268.9 cells/mm^3 Interval 188.5 to 349.3	243.4 cells/mm^3 Interval 165.5 to 321.3	161.3 cells/mm^3 Interval 90.2 to 232.4	—	—

SECONDARY outcome

Timeframe: Baseline and Week 144

Population: All randomized participants who received at least 1 dose of study treatment and have baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Change From Baseline in CD4+ T-cell Count at Week 144	162.9 cells/mm^3 Interval 70.2 to 255.5	270.0 cells/mm^3 Interval 183.2 to 356.8	204.4 cells/mm^3 Interval 102.0 to 306.7	209.0 cells/mm^3 Interval 111.5 to 306.6	—	—

SECONDARY outcome

Timeframe: Baseline and Week 192

Blood samples were collected and CD4+ T-cell counts were performed, where baseline measurements are defined as the Week 144 value. The change from baseline in CD4+ T-cell count at Week 192 (Part 4) are reported.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=57 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=21 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Change From Baseline in CD4+ T-cell Count at Week 192 (Part 4)	—	—	3.8 cells/mm^3 Interval -1.9 to 9.5	-3.4 cells/mm^3 Interval -12.0 to 5.2	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=27 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=28 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Experiencing AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen	14 Participants	16 Participants	18 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks

Population: All randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=27 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=28 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Discontinuing Study Drug Due to AEs Through 24 Weeks After 3TC and Placebo Are Discontinued From the Regimen	2 Participants	1 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Week 96 up to Week 192

Population: Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received were analyzed.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued n=67 Participants In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch n=22 Participants In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Experiencing AEs From Week 96 Through Study Duration	11 Participants	12 Participants	12 Participants	19 Participants	36 Participants	14 Participants

SECONDARY outcome

Timeframe: Week 96 up to Week 192

Population: Per protocol, all randomized participants who received at least 1 dose of open label study treatment in Part 3 or Part 4, corresponding to the study treatment they actually received.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg n=31 Participants In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF n=31 Participants In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=29 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=30 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued n=67 Participants In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch n=22 Participants In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Discontinuing Study Drug Due to AEs From Week 96 Through Study Duration	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 144 up to Week 192

Population: Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=67 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=22 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Experiencing AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)	—	—	36 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: Week 144 up to Week 192

Population: Per protocol, all randomized participants who entered Part 4 and either continued treatment with DOR/ISL from Part 3 or switched from DOR/3TC/TDF in Part 3 to DOR/ISL in Part 4; and received at least 1 dose of study treatment, corresponding to the study treatment they actually received were analyzed.

Outcome measures

Outcome measures
Measure	Islatravir 2.25 mg In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/3TC/TDF In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.25 mg n=67 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	Islatravir 0.75 mg n=22 Participants In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144. In Part 4, beginning with Week 144, participants received the fixed dose combination of doravirine (100 mg)/islatravir (0.75 mg) QD open label and continued treatment until Week 192.	DOR/ISL Continued In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Number of Participants Discontinuing Study Drug Due to AEs During Open Label Doravirine/Islatravir Treatment After Week 144 up to Week 192 (Part 4)	—	—	0 Participants	0 Participants	—	—

Adverse Events

Islatravir 0.25mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Islatravir 0.75mg

Serious events: 6 serious events

Other events: 26 other events

Deaths: 0 deaths

Islatravir 2.25mg

Serious events: 2 serious events

Other events: 23 other events

Deaths: 0 deaths

DOR/3TC/TDF

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

DOR/ISL Continued

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

DOR/ISL Switch

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Islatravir 0.25mg n=29 participants at risk In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	Islatravir 0.75mg n=30 participants at risk In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	Islatravir 2.25mg n=31 participants at risk In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	DOR/3TC/TDF n=31 participants at risk In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144.	DOR/ISL Continued n=67 participants at risk In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch n=22 participants at risk In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Congenital, familial and genetic disorders Long QT syndrome congenital	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
General disorders Death	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Appendicitis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations COVID-19	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Dysentery	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Epididymitis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Large intestine infection	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Pneumonia chlamydial	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Pulmonary tuberculosis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Burkitt's lymphoma	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Nervous system disorders Facial paralysis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Psychotic disorder	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Suicidal ideation	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Suicide attempt	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

Other adverse events

Other adverse events
Measure	Islatravir 0.25mg n=29 participants at risk In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	Islatravir 0.75mg n=30 participants at risk In Part 1, participants were treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 0.75 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	Islatravir 2.25mg n=31 participants at risk In Part 1, participants were treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. In part 2, after receiving at least 24 weeks of study intervention, participants with HIV-1 RNA \<50 copies/mL and no PDVF discontinued treatment of 3TC and placebo to DOR/3TC/TDF. Part 2 assessed ISL 2.25 mg (blind maintained) + DOR QD. After all participants had received at least 48 weeks of study intervention and the islatravir dose was selected, all participants in the islatravir group were switched to the selected dose 0.75 mg (between week 60 and week 84). Part 3 assessed Islatravir 0.75 mg + DOR QD open label through Week 144.	DOR/3TC/TDF n=31 participants at risk In Part 1, participants were treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. In Parts 2 and 3, after a minimum of 24 weeks of treatment, placebo treatments were discontinued and participants received only DOR/3TC/TDF QD open label up to Week 144.	DOR/ISL Continued n=67 participants at risk In Part 4, beginning with week 144, participants who received the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label in Part 3 and continued treatment through Week 192.	DOR/ISL Switch n=22 participants at risk In Part 4, beginning with week 144, participants who received DOR/3TC/TDF QD open label up to Week 144 were switched to the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and continued treatment until Week 192.
Skin and subcutaneous tissue disorders Penile ulceration	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Ear and labyrinth disorders Vertigo	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Abdominal distension	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Abdominal pain	3.4% 1/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Abdominal pain upper	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.0% 2/67 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Diarrhoea	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	20.0% 6/30 • Number of events 8 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	25.8% 8/31 • Number of events 11 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	13.6% 3/22 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	16.7% 5/30 • Number of events 6 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Proctitis	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Gastrointestinal disorders Vomiting	10.3% 3/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
General disorders Asthenia	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
General disorders Fatigue	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	13.3% 4/30 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.0% 2/67 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
General disorders Influenza like illness	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
General disorders Pyrexia	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Immune system disorders Seasonal allergy	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Anal chlamydia infection	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.0% 2/67 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Bronchitis	6.9% 2/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	23.3% 7/30 • Number of events 7 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	16.1% 5/31 • Number of events 7 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations COVID-19	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.0% 2/67 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	22.7% 5/22 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Cellulitis	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Conjunctivitis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Escherichia urinary tract infection	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Folliculitis	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Fungal skin infection	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Gastroenteritis	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Influenza	10.3% 3/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Lower respiratory tract infection	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Nasopharyngitis	6.9% 2/29 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	30.0% 9/30 • Number of events 10 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	22.6% 7/31 • Number of events 14 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Oral herpes	6.9% 2/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Oropharyngeal gonococcal infection	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Otitis media	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Paronychia	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Pharyngitis	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.0% 2/67 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Proctitis chlamydial	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Proctitis gonococcal	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Sinusitis	13.8% 4/29 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Syphilis	20.7% 6/29 • Number of events 6 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	26.7% 8/30 • Number of events 8 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	19.4% 6/31 • Number of events 7 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.0% 4/67 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Tonsillitis	6.9% 2/29 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 8 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Tooth abscess	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Upper respiratory tract infection	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Urethritis	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Infections and infestations Viral pharyngitis	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Investigations Alanine aminotransferase increased	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Investigations Aspartate aminotransferase increased	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Investigations Weight increased	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Metabolism and nutrition disorders Vitamin D deficiency	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	20.0% 6/30 • Number of events 6 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Back pain	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Neck pain	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	10.3% 3/29 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	3.4% 1/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.3% 1/30 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Nervous system disorders Headache	17.2% 5/29 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	16.1% 5/31 • Number of events 6 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	12.9% 4/31 • Number of events 5 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Nervous system disorders Sciatica	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Nervous system disorders Syncope	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Anxiety	10.3% 3/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	20.0% 6/30 • Number of events 7 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.1% 2/22 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Depression	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	4.5% 1/22 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Psychiatric disorders Insomnia	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	9.7% 3/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Cough	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.3% 3/29 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	10.0% 3/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	3.4% 1/29 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	6.9% 2/29 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	1.5% 1/67 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/29 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/30 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/31 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.5% 2/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.
Skin and subcutaneous tissue disorders Rash	10.3% 3/29 • Number of events 4 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	6.7% 2/30 • Number of events 3 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 2 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	3.2% 1/31 • Number of events 1 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/67 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.	0.00% 0/22 • For All-Cause Mortality: from randomization up to 198 weeks. For AEs: from first treatment up to 198 weeks. The population analyzed for All-Cause Mortality was all randomized participants. The population analyzed for AEs was all randomized participants who received at least 1 dose of study treatment, corresponding to the study treatment they actually received.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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