Trial Outcomes & Findings for Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (NCT NCT04233879)

Last Updated: 2026-01-28

Results Overview

The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 was presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The final analysis for this outcome is presented here.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

599 participants

Primary outcome timeframe

Week 48

Results posted on

2026-01-28

Participant Flow

Treatment-naïve participants living with Human Immunodeficiency Virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy were enrolled.

A total of 599 participants were randomized in the study and 597 received at least 1 dose of study intervention. The safety analyses were conducted using all participants as treated population, which included all randomized participants who received at least 1 dose of study intervention.

Participant milestones

Participant milestones
Measure	Group 1: DOR/ISL Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Base Study (Day 1 to Week 144) STARTED	298	301
Base Study (Day 1 to Week 144) Treated	298	299
Base Study (Day 1 to Week 144) COMPLETED	59	34
Base Study (Day 1 to Week 144) NOT COMPLETED	239	267
Extension Study (Week 144 to 168) STARTED	21	27
Extension Study (Week 144 to 168) COMPLETED	0	1
Extension Study (Week 144 to 168) NOT COMPLETED	21	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: DOR/ISL Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Base Study (Day 1 to Week 144) Death	3	0
Base Study (Day 1 to Week 144) Lost to Follow-up	16	17
Base Study (Day 1 to Week 144) Physician Decision	11	7
Base Study (Day 1 to Week 144) Sponsor Decision	168	179
Base Study (Day 1 to Week 144) Withdrawal by Subject	35	34
Base Study (Day 1 to Week 144) Other	6	30
Extension Study (Week 144 to 168) Lost to Follow-up	0	1
Extension Study (Week 144 to 168) Sponsor Decision	20	25
Extension Study (Week 144 to 168) Withdrawal by Subject	1	0

Baseline Characteristics

Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=301 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Total n=599 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=158 Participants	0 Participants n=157 Participants	0 Participants n=315 Participants
Age, Continuous	34.7 Years STANDARD_DEVIATION 11.0 • n=158 Participants	35.7 Years STANDARD_DEVIATION 10.9 • n=157 Participants	35.2 Years STANDARD_DEVIATION 10.9 • n=315 Participants
Sex: Female, Male Female	77 Participants n=158 Participants	71 Participants n=157 Participants	148 Participants n=315 Participants
Sex: Female, Male Male	221 Participants n=158 Participants	230 Participants n=157 Participants	451 Participants n=315 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	123 Participants n=158 Participants	112 Participants n=157 Participants	235 Participants n=315 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants n=158 Participants	184 Participants n=157 Participants	355 Participants n=315 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=158 Participants	5 Participants n=157 Participants	9 Participants n=315 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=158 Participants	2 Participants n=157 Participants	4 Participants n=315 Participants
Race (NIH/OMB) Asian	16 Participants n=158 Participants	20 Participants n=157 Participants	36 Participants n=315 Participants
Race (NIH/OMB) Black or African American	86 Participants n=158 Participants	90 Participants n=157 Participants	176 Participants n=315 Participants
Race (NIH/OMB) White	171 Participants n=158 Participants	169 Participants n=157 Participants	340 Participants n=315 Participants
Race (NIH/OMB) More than one race	23 Participants n=158 Participants	19 Participants n=157 Participants	42 Participants n=315 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=158 Participants	1 Participants n=157 Participants	1 Participants n=315 Participants
Baseline Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Level ≤100,000 copies/mL	244 Participants n=158 Participants	239 Participants n=157 Participants	483 Participants n=315 Participants
Baseline Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Level >100,000 copies/mL	54 Participants n=158 Participants	60 Participants n=157 Participants	114 Participants n=315 Participants
Baseline Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Level Missing	0 Participants n=158 Participants	2 Participants n=157 Participants	2 Participants n=315 Participants
Baseline Cluster of Differentiation 4+ (CD4+) T-Cell Count <200 cells/mm^3	61 Participants n=158 Participants	60 Participants n=157 Participants	121 Participants n=315 Participants
Baseline Cluster of Differentiation 4+ (CD4+) T-Cell Count ≥200 cells/mm^3	237 Participants n=158 Participants	239 Participants n=157 Participants	476 Participants n=315 Participants
Baseline Cluster of Differentiation 4+ (CD4+) T-Cell Count Missing	0 Participants n=158 Participants	2 Participants n=157 Participants	2 Participants n=315 Participants

PRIMARY outcome

Timeframe: Week 48

Population: All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48	88.9 Percentage of participants	88.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 48 weeks

Population: All randomized participants who received at least one dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.

An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one AE up to Week 48 was reported. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48	90.6 Percentage of participants	86.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 48 weeks

An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE up to Week 48 were reported. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48	7.4 Percentage of participants	3.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96	51.7 Percentage of participants	57.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

Population: All randomized participants who received at least one dose of study intervention and had data available for this outcome measure at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 144 was presented using the Data as Observed (DAO) missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=39 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=41 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144	64.1 Percentage of participants	82.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with HIV-1 RNA \<40 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48	88.6 Percentage of participants	86.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

The percentage of participants with HIV-1 RNA \<200 copies/mL was determined. The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48	89.6 Percentage of participants	88.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96	51.0 Percentage of participants	57.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 96 was presented using the FDA Snapshot missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96	52.3 Percentage of participants	58.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=39 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=41 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 144	64.1 Percentage of participants	82.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<200 copies/mL at Week 144 was presented using the DAO missing data approach. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=39 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=41 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 144	64.1 Percentage of participants	82.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 48. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.

Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and at Week 48 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=263 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=263 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48	182.4 cells/mm^3 Interval 162.0 to 202.7	233.5 cells/mm^3 Interval 211.8 to 255.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

Population: All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 96. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.

Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and at Week 96 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 96 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=159 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=168 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 96	217.05 cells/mm^3 Interval 187.52 to 246.58	319.92 cells/mm^3 Interval 290.53 to 349.32

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 144

Population: All randomized participants who received at least one dose of study intervention and had data available, including baseline data available for CD4+ T-cell count at Week 144. Participants were included in the treatment group to which they were randomized. The final analysis for this outcome is presented here.

Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and at Week 144 by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 144 using the Data as Observed (DAO) approach was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=24 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=32 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 144	239.6 cells/mm^3 Interval 177.4 to 301.8	350.9 cells/mm^3 Interval 265.7 to 436.1

SECONDARY outcome

Timeframe: Week 48

Population: Participants with data available at Week 48. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.

RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=3 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=6 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants with data available at Week 96. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.

RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 96 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=5 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=9 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Incidence of Viral RASs at Week 96	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 144

Population: Participants with data available at Week 144. Per protocol, participants who met the definition of confirmed virologic rebound or incomplete virologic response, or who discontinued study intervention for another reason and had HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Among such participants, those with HIV-1 RNA ≥400 copies/mL were included. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.

RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 144 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=5 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=9 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Incidence of Viral RASs at Week 144	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: All randomized participants who received at least one dose of study intervention and had data available, including baseline data available, for this outcome measure at Week 48. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.

Body weight was measured at baseline and at Week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 48 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=270 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=268 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Body Weight at Week 48	3.45 kilogram Interval 2.83 to 4.06	3.32 kilogram Interval 2.68 to 3.96

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

Population: All randomized participants who received at least one dose of intervention and had data available, including baseline data available, for this outcome measure at Week 96. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.

Body weight was measured at baseline and at Week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 96 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=189 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=201 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Body Weight at Week 96	3.31 kilogram Interval 2.45 to 4.18	4.13 kilogram Interval 3.15 to 5.11

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 144

Population: All randomized participants who received at least one dose of study intervention and had data available, including baseline data available, for this outcome measure at Week 144. Participants were included in the treatment group corresponding to the study intervention received. The final analysis for this outcome is presented here.

Body weight was measured at baseline and at Week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in body weight at Week 144 was presented. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=40 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=42 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Mean Change From Baseline in Body Weight at Week 144	4.55 kilogram Interval 2.4 to 6.7	3.55 kilogram Interval -1.46 to 8.56

SECONDARY outcome

Timeframe: Up to approximately 47 months

An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experienced at least one or more AEs is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants Who Experienced an Adverse Event (AE)	96.6 Percentage of participants	94.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 38 months

An AE was any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study intervention due to an AE is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. The final analysis for this outcome is presented here.

Outcome measures

Outcome measures
Measure	Group 1: DOR/ISL n=298 Participants Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF n=299 Participants Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Percentage of Participants Who Discontinued Study Treatment Due to an AE	14.1 Percentage of participants	9.0 Percentage of participants

Adverse Events

Group 2: BIC/FTC/TAF Base Study Week 48 - Week 96

Serious events: 13 serious events

Other events: 124 other events

Deaths: 0 deaths

Group 1: DOR/ISL Base Study Week 0 - Week 48

Serious events: 19 serious events

Other events: 146 other events

Deaths: 2 deaths

Group 1: DOR/ISL Base Study Week 48-Week 96

Serious events: 14 serious events

Other events: 115 other events

Deaths: 0 deaths

Group 1: DOR/ISL Base Study Week 96-Week 144

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Group 2: BIC/FTC/TAF Base Study Week 0 - Week 48

Serious events: 16 serious events

Other events: 141 other events

Deaths: 0 deaths

Group 2: BIC/FTC/TAF Base Study Week 96 - Week 144

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Group 1: DOR/ISL Open-Label Extension Week 144-Week 168

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2: BIC/FTC/TAF Open-Label Extension Week 144 - Week 168

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 1: DOR/ISL Post-Treatment Follow-Up

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Group 2: BIC/FTC/TAF Post-Treatment Follow-Up

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 2: BIC/FTC/TAF Base Study Week 48 - Week 96 n=267 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 0 - Week 48 n=298 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 48-Week 96 n=266 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 96-Week 144 n=146 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Base Study Week 0 - Week 48 n=299 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Base Study Week 96 - Week 144 n=143 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Open-Label Extension Week 144-Week 168 n=21 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Open-Label Extension Week 144 - Week 168 n=27 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Post-Treatment Follow-Up n=112 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Post-Treatment Follow-Up n=128 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Cardiac disorders Acute myocardial infarction	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Cardiac disorders Angina unstable	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Cardiac disorders Heart failure with preserved ejection fraction	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Cardiac disorders Myocardial ischaemia	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Cardiac disorders Pericarditis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Congenital, familial and genetic disorders Exomphalos	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Gastrointestinal disorders Abdominal pain	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Gastrointestinal disorders Enteritis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Gastrointestinal disorders Oesophagitis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Hepatobiliary disorders Cholelithiasis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Hepatobiliary disorders Hepatitis acute	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Immune system disorders Drug hypersensitivity	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.0% 3/298 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Abdominal wall abscess	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Abscess limb	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Acute hepatitis B	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Appendicitis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.67% 2/299 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Bacterial infection	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations COVID-19	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations COVID-19 pneumonia	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Cellulitis	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.67% 2/298 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Cytomegalovirus colitis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Disseminated tuberculosis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Diverticulitis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Gastroenteritis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Infectious pleural effusion	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Influenza	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Lower respiratory tract infection	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Lymphogranuloma venereum	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Neurosyphilis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Peritonitis	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Peritonsillar abscess	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Pneumonia bacterial	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Pneumonia pneumococcal	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.89% 1/112 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Pulmonary tuberculosis	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Scrotal abscess	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Scrotal cellulitis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Sepsis	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Septic shock	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Urinary tract infection	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Craniofacial fracture	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Poisoning	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Stab wound	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.89% 1/112 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Suture rupture	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Investigations CD4 lymphocytes decreased	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Investigations Liver function test increased	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Nervous system disorders Febrile convulsion	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.78% 1/128 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Nervous system disorders Migraine	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.78% 1/128 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Anxiety disorder	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Depression	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.89% 1/112 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Major depression	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.70% 1/143 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Suicidal behaviour	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Suicidal ideation	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Suicide attempt	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.34% 1/298 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Renal and urinary disorders Acute kidney injury	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Vascular disorders Deep vein thrombosis	0.37% 1/267 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Vascular disorders Hypertensive emergency	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/266 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Vascular disorders Peripheral ischaemia	0.00% 0/267 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/298 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.38% 1/266 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/299 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.

Other adverse events

Other adverse events
Measure	Group 2: BIC/FTC/TAF Base Study Week 48 - Week 96 n=267 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 0 - Week 48 n=298 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 48-Week 96 n=266 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Base Study Week 96-Week 144 n=146 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Base Study Week 0 - Week 48 n=299 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Base Study Week 96 - Week 144 n=143 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Open-Label Extension Week 144-Week 168 n=21 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Open-Label Extension Week 144 - Week 168 n=27 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.	Group 1: DOR/ISL Post-Treatment Follow-Up n=112 participants at risk Treatment-naïve participants living with human immunodeficiency virus-1 (HIV-1) that had not received ≤10 days of prior antiretroviral therapy received blinded fixed dose combination (FDC) Doravirine/Islatravir (DOR/ISL) (100 mg doravirine \[DOR\]/0.75 mg islatravir \[ISL\]) and placebo to Bictegravir/Tenofovir Alafenamide/Emtricitabine (BIC/FTC/TAF) once daily (QD) from Day 1 to Week 96, and open-label DOR/ISL up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive open-label QD FDC of DOR/ISL (100 mg/0.75 mg) for an additional 24 weeks, up to Week 168.	Group 2: BIC/FTC/TAF Post-Treatment Follow-Up n=128 participants at risk Treatment-naïve participants living with HIV-1 that had not received ≤10 days of prior antiretroviral therapy received blinded BIC/FTC/TAF (50 mg bictegravir \[BIC\], 200 mg emtricitabine \[FTC\], 25 mg tenofovir alafenamide \[TAF\]) and placebo to FDC DOR/ISL QD from Day 1 to Week 96, and open-label BIC/FTC/TAF up to Week 144. At Week 144, participants who consent to enter the optional open-label study extension continued to receive QD BIC/FTC/TAF (50 mg/200 mg/25 mg) for an additional 24 weeks, up to Week 168.
Gastrointestinal disorders Diarrhoea	1.9% 5/267 • Number of events 5 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	8.7% 26/298 • Number of events 28 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.3% 6/266 • Number of events 7 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/146 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	6.7% 20/299 • Number of events 21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/143 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.78% 1/128 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations COVID-19	10.9% 29/267 • Number of events 29 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	14.1% 42/298 • Number of events 45 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	7.5% 20/266 • Number of events 21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/146 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	15.7% 47/299 • Number of events 49 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.1% 3/143 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	3.7% 1/27 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.78% 1/128 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Infections and infestations Upper respiratory tract infection	4.1% 11/267 • Number of events 11 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.0% 15/298 • Number of events 16 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.3% 14/266 • Number of events 14 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.7% 4/146 • Number of events 4 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.0% 15/299 • Number of events 18 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.8% 4/143 • Number of events 4 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	6.2% 7/112 • Number of events 8 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Injury, poisoning and procedural complications Accidental overdose	6.4% 17/267 • Number of events 24 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.7% 17/298 • Number of events 21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.6% 7/266 • Number of events 12 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	2.1% 3/146 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.4% 16/299 • Number of events 24 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.70% 1/143 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Investigations CD4 lymphocytes decreased	9.4% 25/267 • Number of events 28 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.67% 2/298 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	10.5% 28/266 • Number of events 35 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	8.2% 12/146 • Number of events 13 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.33% 1/299 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	9.8% 14/143 • Number of events 17 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	3.7% 1/27 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Investigations Lymphocyte count decreased	20.6% 55/267 • Number of events 62 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	9.1% 27/298 • Number of events 28 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	24.1% 64/266 • Number of events 75 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	17.1% 25/146 • Number of events 29 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	4.0% 12/299 • Number of events 12 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	16.8% 24/143 • Number of events 27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	14.3% 3/21 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Investigations Weight increased	3.0% 8/267 • Number of events 8 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	6.4% 19/298 • Number of events 19 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.75% 2/266 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/146 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	6.0% 18/299 • Number of events 18 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.70% 1/143 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	3.7% 1/27 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.89% 1/112 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 5/267 • Number of events 6 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	5.4% 16/298 • Number of events 17 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	4.1% 11/266 • Number of events 12 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/146 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	4.7% 14/299 • Number of events 16 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/143 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/112 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Nervous system disorders Headache	4.9% 13/267 • Number of events 15 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	10.4% 31/298 • Number of events 36 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	4.9% 13/266 • Number of events 14 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/146 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	11.4% 34/299 • Number of events 38 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.4% 2/143 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.89% 1/112 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.
Psychiatric disorders Insomnia	1.1% 3/267 • Number of events 3 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	4.4% 13/298 • Number of events 14 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.5% 4/266 • Number of events 4 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.68% 1/146 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	6.4% 19/299 • Number of events 20 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.70% 1/143 • Number of events 1 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/21 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/27 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	1.8% 2/112 • Number of events 2 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.	0.00% 0/128 • Up to approximately 47 months All-cause mortality: all randomized participants; AEs: all randomized participants who got ≥1 dose of study drug. Both reported for base study \& open-label extension. Per protocol, "post treatment follow up" denotes participants monitored after drug discontinuation with drops in CD4+/ total lymphocyte count. Per protocol, infant serious AEs (febrile convulsion \& exomphalos) \& pregnancy-related AEs were collected on pregnant participants enrolled; included by the arms that participants enrolled.

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 The sponsor will comply with the requirements for publication of study results. The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER